All articles

• September 13, 2023

Best life science vendor, best usability, best set-up, best results! Qualio at G2 Fall 2023

• August 10, 2023

Fresh features and time-saving shortcuts in our latest product release

• August 09, 2023

PMA submissions: 4 PMA application methods for medical devices

• July 20, 2023

Guide to 21 CFR Part 11 compliance [free checklist]

• July 19, 2023

PMA meaning: understanding FDA pre-market approval

• July 11, 2023

What is GxP in pharma?

• July 03, 2023

The ultimate ISO 9001 overview: quality management systems

• July 03, 2023

How to get an ISO 17025 certification

ISO 17025 certification is the international quality benchmark for the modern testing and calibration laboratory.

• July 03, 2023

21 CFR Part 820: the complete overview

• June 30, 2023

Guide to ICH E6 (R3): changes and preparation

Quality management

• June 26, 2023

The hidden costs of a free quality management system

• June 23, 2023

Summer of customer love: more Qualio accolades at the G2 Summer Awards

• June 21, 2023

What is ICH E6 R2? Good clinical practice explained

• June 15, 2023

What is ISO 15189? A complete overview

• June 14, 2023

Powerful quality analytic insights in our latest product launch

Quality management

• June 09, 2023

What is quality assurance?

• June 06, 2023

5 fundamentals of the CAPA quality process

The CAPA quality process, in a nutshell, consists of the specific improvements a regulated organization makes to its processes to eliminate defects ...

Medical Devices

• May 24, 2023

The TGA's essential principles explained

• May 17, 2023

What you need to know about ICH Q8

• May 15, 2023

ICH Q9 quality risk management: an introduction

Medical Devices

• May 10, 2023

The complete guide to passing ISO 13485 audits

Medical Devices

• April 26, 2023

Top 6 conferences in Australia for life science companies in 2023

As Australia emerges as a vibrant, expanding market for the life science industry, we've turned our eyes towards some of the key industry events ...

• April 26, 2023

What you need to know about FDA 21 CFR Part 211

• April 21, 2023

What you need to know about FDA 21 CFR Part 210

• April 19, 2023

Faster access to your quality landscape with our latest product upgrades

• April 18, 2023

Ernie Wallerstein, Jr., CEO of Mental Health Technologies

How can technology be used to treat - and even model and predict - mental health? Ernie Wallerstein, CEO of Mental Health Technologies, thinks he has ...

• April 17, 2023

Top 10 conferences for life science companies in 2023

• April 14, 2023

Spring in our step at the G2 Spring Awards 2023

• April 14, 2023

Guide to GxP compliance: processes, challenges and tools

• April 05, 2023

Top pharmaceutical companies: 5 start-ups to watch in 2023

• April 05, 2023

Enabling the next generation of biomarker discovery with Dr. Mo Jain, CEO of Sapient

Lifesaving drugs only work 50% of the time. The reason? Broad-stroke treatments that gloss over the individual variations in our bodies. For Dr. Mo ...

• March 29, 2023

Getting treatment to patients faster by focusing on your strengths: with Keith Wood, COO of argenx

The immune system has extraordinary power to protect and maintain the body - but unchecked, it can also harm and damage. argenx's first-in-class ...

Quality Systems

• March 16, 2023

Mastering quality management in laboratory environments: 12 essential techniques for 2023

• March 15, 2023

What all medtech founders should know: with Duane Mancini, CEO of Project Medtech

Lots of ambitious people dream of starting a successful medtech company. But what does it actually involve? And where can you turn for good, ...

• March 14, 2023

What is cGMP in the pharma industry? 7 experts explain

• March 07, 2023

What is an ICH Q10 pharmaceutical quality system?

Medical Devices

• March 03, 2023

25 impressive medical device startups to watch in 2023

As history has shown, it only takes one ground-breaking medtech startup to change a product category forever.

• March 03, 2023

5 secrets to securing medical device venture capital in 2023

• March 01, 2023

What are the 5 best options for nonconformance management software in 2023?

• February 28, 2023

Programming humanity into AI to improve clinical trials with Chuck Rinker, CEO of PRSONAS

What do video games have to do with clinical trial engagement? And what can the 'uncanny valley' tell us about digital AI? For Chuck Rinker, the ...

Medical Devices

• February 24, 2023

ISO 13485 vs. ISO 9001: understanding the key differences for medical devices

• February 20, 2023

Pharmaceutical quality management software (QMS): our top picks for 2023

• February 17, 2023

5 notorious compliance issues in the pharmaceutical industry

Does the prospect of getting an FDA 483 letter keep you up at night? You’re certainly not alone. Compliance pressures in pharma have never been ...

Medical Devices

• February 07, 2023

The 7 best medical device consultants to work with in 2023

Hiring an experienced medical device consultant in 2023 can streamline even your most complicated go-to-market projects and help you jump challenging ...

Quality management

• February 03, 2023

What is a quality management system (QMS)?

• February 01, 2023

Unlocking scientific data with Mike Tarselli at TetraScience

TetraScience's mission isn't too different from Qualio's: they believe in the power of grabbing and unlocking cloud-based data to save patient lives. ...

• January 30, 2023

510(k) submission checklist to get your medical device to market

• January 25, 2023

The 3 FDA medical device classes: differences and examples explained

Computerized System Assurance

• January 19, 2023

Complete guide to computer system validation in 2023

• January 19, 2023

Qualio donates 1% of revenue to charity for a third consecutive year

• January 18, 2023

5 tips for quality management compliance

Document Control

• January 18, 2023

We just launched the best native document editor on the eQMS market

If documents are the lifeblood of your quality management system, then easy and logical document creation is the beating heart. Other eQMS platforms ...

• January 16, 2023

Complete guide to the MDSAP's nonconformity grading system

• January 12, 2023

When to submit a 510(k) vs. a Premarket Approval

• January 04, 2023

5 benefits of a quality management system (QMS) in 2023

Implementing a quality management system (QMS) can offer noticeable benefits to your entire organization. Recognizing and communicating these ...

• January 03, 2023

8 ways to fail an ISO audit in 2023

A common word of encouragement you'll hear from colleagues when they find out that you're facing an ISO audit: "Good luck!" Of course, luck isn't a ...

• January 02, 2023

A comprehensive review of the best 21 CFR Part 11 software in 2023

There are multiple 21 CFR Part 11 software providers that can help you meet the requirements of the FDA's electronic record regulations. But a ...

• January 01, 2023

How to choose ISO 13485 QMS Software in 2023

For medical device companies looking for quality management system (QMS) software in 2023, evaluating solutions based on ISO 13485 can offer numerous ...

Medical Devices

• December 27, 2022

The top 7 medical device consulting firms you should consider for 2023

Which are the top medical device consulting firms your business should look at as we approach 2023? The right consultant expertise can speed up your ...

Medical Devices

• December 22, 2022

The 6 most common triggers for FDA 21 CFR 820 non-compliance in 2022

• December 20, 2022

Taking diagnostics to the future with Mehdi Maghsoodnia, CEO of 1Health

The future of healthcare depends on fast, targeted and effective treatment. And for that, rapid diagnostics are indispensable. We invited Mehdi ...

• December 15, 2022

2023 is nearly here. Time to reflect on another successful year!

Industry Awards

• December 14, 2022

Qualio smashes customer review records at G2 Winter 2023 Awards

Product Updates

• December 12, 2022

Even faster and easier training with Training Plans

Keeping your colleagues up-to-date with role-specific training is vital for any life science business. And for Qualio customers, keeping up with your ...

• December 12, 2022

510(k) exempt medical devices: how to tell if you need to submit

• December 09, 2022

Modernizing the Lab with Nathan Clark Cofounder of Ganymede

What does a modern life science lab look like? How much manual data processing will take place? Hopefully very little if Ganymede continues to make ...

• December 06, 2022

How to build a complaint management system

What’s more dreadful than receiving a customer complaint? Being asked by a regulatory auditor how you handled the complaint and if you effectively ...

• December 01, 2022

What's the best eQMS software in 2023? [Top 5 options]

An electronic quality management system (eQMS) doesn’t just make life easier for quality teams. As the life science world gets increasingly ...

Medical Devices

• November 30, 2022

What the FDA's new MDDS guidance means for you

The medical device world, like almost every other industry on Earth, gets more digitized by the day. So it's no surprise to see industry bodies like ...

• November 29, 2022

Everything you need to know about the FDA 510(k) submission

What is an FDA 510(k) submission - and how do we complete one?

• November 23, 2022

The 5 best pharmaceutical consultants to work with in 2023

Thinking of hiring an experienced pharmaceutical consultant in 2023? The right expert can lift your business to the next level, helping you embed ...

Medical Devices

• November 22, 2022

8 best ISO 13485 training programs in 2023

The caliber of your organization’s ISO 13485 training has a significant impact on the success and effectiveness of your quality programs. In fact, ...

• November 21, 2022

The top 6 pharmaceutical consulting firms you should consider for 2023

Thinking of working with a pharmaceutical consulting firm in 2023? We've assembled a list of the top 6 you should consider. The right consultant team ...

• November 21, 2022

From Emergency Medicine to Disrupting EHR Technology with Dr. Brian Fengler, Co-founder of EvidenceCare

Dr. Brian Fengler joins us on the show to talk about the latest in healthtech and innovating EHR technology to save lives in fewer clicks. Brian is ...

Medical Devices

• November 18, 2022

The 4 best ISO 13485 audit checklists

An ISO 13485 audit can make even the most seasoned medical device quality managers bite their nails. The standard includes 77 clauses, so there are a ...

Medical Devices

• November 16, 2022

Everything you need to know about ISO 13485

• November 14, 2022

Engineering quality in organizations to better meet patient needs with Matt Wictome from Datod Consulting

We've know many who have or had the job title of "Quality Engineer" however many outside the industry may not consider "quality engineers" to be ...

• November 09, 2022

How Dogs Can Be Used in Research and Science with Kayla Fratt Co-Founder of K9 Conservationists

We’re going to deviate from our typical life sciences for just a few moments just for fun to talk about dogs. We’ve heard about dogs using their ...

Product Updates

• November 08, 2022

The next wave of Qualio upgrades arrives

Medical Devices

• November 01, 2022

The FDA's plans to harmonize FDA 21 CFR Part 820 and ISO 13485 explained

The United State Federal Drug Administration (FDA) plans to present a draft revision of its Quality System Regulation— FDA 21 CFR 820—that brings it ...

• October 26, 2022

How to get to market faster with medical device outsourcing with Jeff Barrett, CEO of J-Pac Medical

We're excited to dive into the world of full-service medical outsourcing with Jeff Barrett, President and CEO OF J-Pac Medical. Jeff Barrett has more ...

• October 20, 2022

A step-by-step guide to internal quality audits

Gearing up for a quality audit is no small feat. Whether it’s your organization’s first time being audited or the 100th, there’s always room for ...

Computerized System Assurance

• October 19, 2022

Qualio launches new validation approach

• October 18, 2022

Using Advanced AI to Curate Individualized Cancer Treatments with Navid Alipour, CEO of AI Med Global

Today, we are chatting with Navid Alipour. Navid is the founder and CEO of AI Med Global. Navid believes that with consistent advancements in the ...

Medical Devices

• October 17, 2022

How to manage nonconformances in medical devices

It's important for medical device manufacturers to have a clear understanding of nonconformances—often referred to as NCs—and how to properly manage ...

• October 10, 2022

9 core elements of a quality management system [Examples]

Every life science company knows that quality is of the utmost importance. But defining quality and aligning that definition to regulations requires ...

• October 05, 2022

The ultimate guide to change control for life sciences companies

For any organization that makes a product, it's important to have change controls in place, but what are change controls? How do they differ from ...

• September 28, 2022

Testing a Gene Therapy to Cure HIV & Fundamentally Change Healthcare with Jeff Galvin of American Gene Technologies®

Today, we are excited to chat with Jeff Galvin, CEO of American Gene Technologies®. We are so glad to have Jeff back on the show, we first spoke with ...

Industry Awards

• September 23, 2022

Qualio takes prizes at the G2 Fall Awards 2022

• September 22, 2022

Helping Medical Device Companies Accelerate Launches to Market with CiteMed's Ethan Drower

Today, we are chatting with Ethan Drower, co-founder and operating partner of CiteMed, which is revolutionizing the European Union Medical Device ...

• September 22, 2022

What are the types of quality audits?

Audits. If you work in life sciences, you know that quality audits are a part of creating life changing products. Though all quality audits aim to ...

Computerized System Assurance

• September 20, 2022

What do the FDA's new CSA guidelines mean?

Medical Devices

• September 19, 2022

Understanding post-market surveillance for medical devices

After spending years developing and testing your medical device, getting it to market is an exciting achievement. But your job isn't done yet. Once ...

Medical Devices

• September 14, 2022

What is a bill of materials? A guide for medical devices

When you first embark on building a new piece of furniture, you’re usually holding a small booklet that outlines every part inside your box. Lining ...

• September 14, 2022

Product and Software Development for MedTech Solutions with Piotr Zajac, CEO of Untitled Kingdom

What does the future of med tech look like? Piotr Zajac of Untitled Kingdom is tackling just that with his team and company. As they say, equality ...

Computerized System Assurance

• September 13, 2022

The 10 key changes in the GAMP 5 Second Edition

The GAMP 5 Second Edition, the newest version of the ISPE's computerized system guidance, was released in July 2022, replacing the First Edition ...

• September 09, 2022

Finding Root Causes of Conditions by Looking at Genetics with Dr. J Dunn

Ever wondered about your genes and overall health? In today's episode, we will talk about just that with Dr. J Dunn. We go over wholistic kinesiology ...

Medical Devices

• September 01, 2022

Everything you need to know about Design History Files (DHF)

One of the most important things a medical device company can do to help bring products to market quickly is to stay organized. If your team isn't ...

• August 30, 2022

21 CFR Part 11: Compliance in the supply chain [Checklist]

21 CFR Part 11 applies to any official quality or manufacturing records pertaining to the design, development, or manufacture of a drug or device ...

Medical Devices

• August 23, 2022

What you need to know about medical device validation

When medical devices work properly, they keep us healthy, moving, monitored, and—in some cases—alive. They're a growing sector in the healthcare ...

• August 18, 2022

Marketing must-knows for healthcare companies with Webtek Interactive

Are you a life sciences start-up founder and want to bring your business to market, but don't know how? Marketing is something that is ever-evolving ...

• August 16, 2022

How to start a pharmaceutical company

Starting your own business takes time, energy, and money—and if you're building a pharmaceutical startup, there’s even more to consider.

• August 09, 2022

21 CFR Part 11: A guide for clinical trial compliance

When conducting or managing any part of a clinical trial, from pre-study through close-out, compliance with 21 CFR Part 11 is always required. The ...

• August 02, 2022

What is GxP in the life sciences industry?

• August 01, 2022

What is an electronic batch record?

According to a report from the Food and Drug Administration (FDA), more than 400 organizations receive a letter for not complying with standard ...

• July 28, 2022

The pros & cons of pharmaceutical contract manufacturing

Manufacturing a new drug is an expensive process, especially for startups with limited resources. That’s why many biopharmaceutical and ...

Medical Devices

• July 26, 2022

A complete guide to 21 CFR Part 11 for medical device manufacturers

Making sure that medical devices meet the required quality standards is essential to protecting public safety. In order to ensure compliance, medical ...

• July 19, 2022

How to choose CAPA software: 8 essential functions

• July 12, 2022

Home testing for everyone, everywhere with Paul Chapman of Domus Diagnostics

We all experienced the importance of at-home testing from the Covid19 pandemic and today's guest is helping bring rapid, affordable, and accurate ...

Medical Devices

• July 05, 2022

Medical device quality management system template: 8 powerful options

Starting a medical device company is an immense task. You have plans to make, employees to hire, funding to obtain, and on top of all that, you have ...

• July 01, 2022

Building a Digital Health Startup with Shuo Qiao of Moving Analytics

Today on the show we're joined by Shuo Qiao, Co-founder and Chief Technology Officer of Moving Analytics. We discuss his career path and how it ...

• June 30, 2022

6 biotech incubators for startups in the U.S.

The cost of getting a biotech startup off the ground is high. Founders not only need to find the right partners, but they must also consistently ...

• June 28, 2022

Saving Lives and Early Cancer Detection with David Suhy of Earli

Can a chemical found in citrus fruit curb cancer and save lives through early detection? Today on the show, we'll talk about the possibilities with ...

Medical Devices

• June 28, 2022

A comprehensive guide to ISO 14971: Risk management for medical devices

This is a guide for medical device professionals looking to gain a deeper understanding of the risk management process and how it may be applied. A ...

Industry Awards

• June 27, 2022

Qualio maintains momentum at the G2 Summer Awards 2022

• June 21, 2022

Navigating FDA Clearance and Launching a Medical Device with Dr. Heather Underwood of EvoEndo

Today we’re catching up with Dr. Heather Underwood, CEO of EvoEndo. EvoEndo recently completed an $8.4 million Series A financing round on the heels ...

• June 17, 2022

The 5 best spots in the United States to start a life science company

• June 16, 2022

Biotech vs pharma: Differences and similarities

To laypeople, the words “biotech” and “pharma” might seem interchangeable. But when you understand the difference between biotech vs. pharma, you can ...

• June 15, 2022

Entrepreneurship and Representation in Healthcare Technology with Gulé Sheikh

Today we speak with developer turned health-tech founder Gulé Sheikh. We discuss her innovations and entrepreneurship at a leading tele-health ...

Medical Device Start-Up

• June 13, 2022

How to start a medical device company

Medical Devices

• June 09, 2022

A practical guide to implementing Risk Management for medical device startups

Risk Management continues to be a hot topic in the medical device world as regulators place additional emphasis on the role of risk management ...

• June 03, 2022

The Benefits of Helmet-Based Ventilation with Aurika Savickaite

Non-invasive ventilation (NIV) is a life-saving tool used throughout ICUs to manage respiratory failure. The traditional form of non-invasive ...

• June 03, 2022

How Artificial Intelligence Can Accelerate Drug Discovery and Bridge the Translational Gap with Jo Varshney of VeriSIM Life

The average cost of developing a new drug is estimated at over $2 billion. Roughly 10% of pre-clinical drugs ever make it to human trials. And each ...

• May 31, 2022

5 tips for pitching your life science company to investors

• May 27, 2022

5 ways to make the FDA audit process easier for your life sciences company

Benjamin Franklin once said that two things in life are certain—death and taxes—and if you’re running a life sciences company, add going through the ...

• May 26, 2022

Rebuilding Biopharma & Personalized Precision Medicine with Diego Rey Cofounder of Endpoint Health and YC Grad

What if you started a company like Roche (est. in 1896) from the ground up? How would you approach drug development differently given enabling ...

• May 26, 2022

The EU IVDR: everything you need to know (Ultimate Guide)

The In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746, better known as the EU IVDR, goes live today!

• May 19, 2022

Qualio launches triple integration release

• May 16, 2022

Catalyzing Chemical Reactions & Scientific Collaboration with Nobel Laureate David MacMillan

What’s the background of a Nobel Prize winner in chemistry, where are the next innovations in science, and how do you say “asymmetric ...

Medical Devices

• May 11, 2022

How SaMD companies can use a QMS to improve regulatory compliance

Nearly a decade ago, the International Medical Device Regulators Forum (IMDRF) released its guidelines for Software as a Medical Device (SaMD). ...

• May 10, 2022

Qualio: officially Best Place To Work!

I'm really pleased to announce that Qualio has made the list of Inc. Magazine's Best Workplaces of 2022 with an overall employee satisfaction score ...

• May 06, 2022

The History and Innovation of CPR and EPR with Lyn Yaffe, CEO of EPR Technologies

Today, we have Lyn Yaffe joining us. Lyn is the Co-founder, Chairman, and CEO of EPR-Technologies. EPR Technologies is a biomedical spinoff of the ...

• April 28, 2022

Accelerating Medtech's time to market with a modern regulatory strategy with James Gianoutsos, Founder of Rimsys

Regulatory landscape is growing increasingly complex with new European Union Medical Device Regulations (EU MDR) and In Vitro Diagnostic Regulations ...

• April 27, 2022

Outsourcing to a contract organization? You still need an eQMS. Here's why.

I recently attended the American Biomanufacturing Summit in San Francisco. It sure was nice to be back in person! The company booth was lovely and, ...

• April 26, 2022

A guide to writing Corrective and Preventive Action (CAPA) reports

It’s stressful to receive an observation or warning letter from the Food and Drug Administration for corrective and preventive action (CAPA) ...

• April 19, 2022

Software as a medical device: Definition, examples, and regulatory trends

Software has “eaten” many industries ever since investor Marc Andreessen penned his famous column ten years ago. And the healthcare industry is no ...

• April 19, 2022

Modernizing the EUMDR Clinical Evaluation Report Process with Ethan Drower Co-founder of CiteMed

Adopting EU MDR is either going to make or break some regulatory teams. With some major updates to EU MDR in the past couple years, the need for ...

• April 11, 2022

Using AI & Virtual Patients to Make Clinical Trials Safe, Affordable, and Scalable with François-Henri Boissel CEO of Novadiscovery

One of the primary issue plaguing R&D for new drugs is the experimental discovery (trial & error) process. Success rate is very low and ...

• April 07, 2022

Tips for passing your MHRA inspection

• April 06, 2022

Empowering Women With Personal Fertility Knowledge with Dr. Amy Beckley of MFB Fertility

Dr. Amy Beckley, founder and CEO of MFB Fertility and inventor of the Proov fertility test joins the show to talk about her journey as a scientist ...

• March 31, 2022

How to build a quality culture in startups. Panel discussion with 5 quality experts.

To be truly successful, quality must go beyond just meeting compliance requirements. When quality is a core practice at a company, everyone from the ...

• March 31, 2022

Empowering parents & caregivers to identify toxic stress in children with Bryon Bhagwandin CEO of Recalibrate Solutions

Stress is part of life but a dysregulated stress system should not be. Unfortunately, many children experience stress so frequently that it becomes ...

Medical Devices

• March 30, 2022

Everything You Need to Know About Design Controls for Medical Devices

Navigating the medical device regulatory environment can seem daunting at times, and it's easy to get lost in the technical jargon of the standards. ...

• March 29, 2022

Scaling insulin production with Cameron Owen, CEO/co-Founder of rBio

It's not hard to find someone who has been affected by diabetes and the rising cost of insulin. In fact, today's guest says that 1 in 10 people in ...

• March 29, 2022

Overcoming barriers in infrastructure and human capital with Joseph Mocanu PhD from Verge Healthtech Fund

You may have heard the adage, "an ounce of prevention is worth a pound of cure." Today's guest Joseph Mocanu, PhD shares how companies and ...

• March 28, 2022

Improving Healthcare Access for Vulnerable Populations in 2021

This past year—much like the year before—has put increasing pressure on professionals working in life sciences and healthcare. We hear the inspiring ...

• March 23, 2022

Creating “future proof” antibodies vs. virus variants like Omicron with Ian Chan, co-founder of Abpro

Today's guest is Ian Chan the co-founder and executive chairman of Abpro. Abpro is improving the lives of mankind facing severe and life-threatening ...

• March 23, 2022

Harnessing Digital Talent to Solve Crises with Courtney Brown from WHO & The Millennial Group

About Courtney: Courtney Brown started her career within Australia’s first digital banking proposition, ING Direct. She is dynamic and performance ...

• March 23, 2022

Remote auditing: tips for the future

The pandemic may have made remote audits a necessity, but there’s no reason they shouldn’t be here to stay.

Industry Awards

• March 23, 2022

Qualio starts 2022 the right way at the G2 Spring Awards

Qualio has continued to build our successful presence on the technology review platform G2 by placing first in 4 key areas in the Medical QMS ...

Quality Systems

• March 11, 2022

Eulogy for Q. Emmess

Today, as Qualio publishes our 2022 life science quality trends report which reveals that almost half of quality professionals have already digitized ...

• March 10, 2022

Restoring Hearing Loss with Novel Therapeutics with Laurence Reid CEO of Decibel Tx

Did you know that hearing loss is one of the largest areas of unmet need in medicine? It affects approximately 466 million people worldwide, ...

• March 07, 2022

Rethinking Your Market Access Strategy with Dinesh Kabaleeswaran, Sr. Dir. of Insights and Advisory at MMIT

Today's episode we explore the ins and outs of market access strategy with Dinesh Kabaleeswaran, Sr. Dir. of Insights and Advisory at MMIT. Learn ...

Quality Systems

• February 24, 2022

Quality Assurance vs. Quality Control Explained: 5 key differences

• February 22, 2022

Tips for moving from a paper-based QMS to an eQMS

Paper-based quality management systems have been a mainstay for life sciences organizations. A paper-based approach can be easy to stand up within an ...

• February 11, 2022

European Market Strategy, Acquisitions and Disrupting the Drug Discovery Value Chain with Tanja Dowe from Debiopharm Innovation Fund

We're excited to have, from all the way in Switzerland, Tanja Dowe the CEO of Debiopharm Innovation Fund on the show. Tanja has a background in ...

• February 10, 2022

Busting myths about eQMS vendors

“Are you guys certified to ISO 13485? How about ISO 14971? The IVDR transition period is about to end and the industry is scrambling, do you guys ...

• February 04, 2022

Changing the Game for Drug Delivery with Robert Niichel, CEO of SmartTab

Robert Niichel the CEO of SmartTab is creating ingestible capsules for drug delivery of biologics and targeted medications. Think of a pill you take ...

• February 04, 2022

3 thoughts about quality software integrations

• February 03, 2022

The quality manager's guide to rapid eQMS success: validation, adoption and implementation

Electronic quality management systems (eQMS) were generally limited in their infancy to costly, custom on-premise platforms developed specifically ...

• January 26, 2022

Meet the Qualio customer success team

Our customer success team are a friendly bunch. They're here to make Qualio customers happy and successful quality professionals with complete ...

• January 25, 2022

How a quality assurance director freed up a week each month for continuous improvement using Qualio

New York-based Koneksa provides digital biomarker technologies for the remote capture of clinical trial data.

• January 24, 2022

The FDA's approach to digital health technology (DHT) is changing. That's a big deal.

In December 2021, the FDA revealed its draft guidance on "Digital Health Technologies for Remote Data Acquisition in Clinical Investigations".

Medical Devices

• January 17, 2022

The 4 Best Medical Device Quality Assurance Training Options

Organizations spend $12 billion a year on quality assurance, which seems like a lot until you learn they lose twice that amount on issues related to ...

• January 12, 2022

What Are The Essential Elements of Pharmaceutical Quality Management Systems? [8 Examples]

If you aren’t following current good manufacturing practices (cGMP), ISO standards or ICH Q10 guidance, you’re leaving yourself open to making errors ...

• January 10, 2022

6 strategies for successful biotech funding

The biotech industry is booming. In 2020, venture biotech funding reached $36.6 billion, according to McKinsey & Company. With the way the ...

• December 22, 2021

Qualio as a Force for Good: Year 2 of Improving Healthcare Access for Vulnerable Populations

• December 17, 2021

What the FDA's new draft software guidance tells us

November finally saw the release of the FDA's new draft guidance on premarket software submission content.

• December 16, 2021

Ultimate guide to Qualio integrations

Integrations aren't just about making your life easier and your work faster – though of course that's important.

Quality Systems

• November 29, 2021

Understanding the Scope of Quality Assurance in the Pharmaceutical Industry

It can be a challenge to maintain a company-wide dedication to quality assurance for therapeutics and pharmaceuticals. When you have a product that ...

Medical Devices

• November 24, 2021

How Much Is the FDA Medical Device Registration Fee in 2022?

For the fiscal year of of 2022, the Food and Drug Administration (FDA) medical device registration fee rates increased by 2.5% from 2021. Considering ...

• November 18, 2021

New look, same mission at Qualio

Today we’re excited to share Qualio’s new brand identity.

• November 11, 2021

Creating a culture of quality at Synthego

Synthego is a genome engineering company that leverages machine learning, automation, and gene editing technologies to accelerate life science ...

• November 09, 2021

Treating Previously Undruggable Diseases: Dr. Ian Taylor at Arvinas

Subscribe on any major podcast player. Most likely everyone reading this has been affected by cancer or knows someone who has had cancer. Using ...

• November 03, 2021

Meet Qualio Plus: Sidekick Health Chooses Qualio for Audit-Readiness

Sidekick Health is a software company founded by medical doctors and specialists that operates a gamified digital care platform designed to help ...

Medical Devices

• October 22, 2021

What all medical device founders should know with John Kapitan, CEO of Kapstone Medical

Subscribe on any major podcast player. Today's guest, John Kapitan is the CEO of Kapstone Medical, a company he founded in 2007 after 15 years in the ...

Document Control

• September 30, 2021

4 Things Pharmaceutical Startups Need for Document Management

Imagine this: your pharmaceutical company is close to receiving full FDA approval for your new drug—but then the FDA comes back to you with multiple ...

Medical Devices

• September 21, 2021

What is FDA Emergency Use Authorization

In recent months, the U.S. Food and Drug Administration (FDA) has used Emergency Use Authorizations (EUA) to accelerate the development and approval ...

• September 15, 2021

Reducing Time to Market for Pharma Companies with Rapid Payer Response

Subscribe on any major podcast player. Typically, it takes several months for third-parties and consultants in the life sciences industry to get data ...

Quality Systems

• September 09, 2021

4 Examples of Continuous Improvement in Quality Management in Life Sciences Companies

We all know that quality management isn't a "set it and forget it system," but how do you actually make continuous improvement in quality management ...

Medical Devices

• August 31, 2021

What is a Device History Record (DHR)? [Definition and Components]

Read below if you would like more information regarding Device History Records and its different components. What is the best way to ensure that your ...

• August 25, 2021

Bring life-saving medical devices to market faster with Qualio Design Controls

• August 24, 2021

The Risks of ISO 9001 Nonconformance

Concerned about ISO 9001 nonconformance? You're not alone. Almost all organizations receive a nonconformance notification at some point. The question ...

Medical Devices

• August 19, 2021

What are the 6 Essentials of a Clinical Evaluation Report (CER) for Medical Device Organizations?

Listen to the audio version of this article read by a real person here (Sound on!): If you've never completed a medical device clinical evaluation ...

Medical Devices

• August 17, 2021

What is the Device Master Record (DMR)?

The 21 CFR 820.181 regulation requires all medical device manufacturers to maintain concrete records related to device specifications, quality ...

• August 12, 2021

How to respond to FDA warning letters

What’s the fastest way to ruin a quality manager’s day? Receiving a warning letter from the United States Food and Drug Administration (FDA). ...

Medical Devices

• August 10, 2021

3 FDA Design Control Requirements for Medical Device Startups

Did you know that design issues are the largest source of product recalls in the United States? Poorly designed products pose a serious threat to ...

• August 05, 2021

Rapidly Discovering and Extracting Natural Pharmaceuticals

Subscribe on any major podcast player. Mental health issues have been on the minds of many as athletes are under tremendous pressure to perform ...

Medical Devices

• August 03, 2021

What Is the Unique Device Identification (UDI) System and Why Is it Important?

If you’re preparing to introduce a new medical device to market, labelers must first secure a unique device identifier. In case you’re unfamiliar, ...

Medical Devices

• July 27, 2021

How Long Does the FDA Medical Device Approval Process Take? [Timeline]

How long before your medical device startup runs out of money? That depends on how long it takes before you start generating revenue. And generating ...

• July 22, 2021

Identifying the 4 Most Common Problems With Your CAPA Process

Over the years, we’ve heard from thousands of life sciences start-up founders and quality managers. As an industry-leading quality management system ...

• July 20, 2021

5 Major Total Quality Management Principles for Medical Device Startups

What is total quality management (TQM) as it relates to the life sciences industry? A bulletproof TQM strategy outlines the strategies manufacturers ...

Medical Devices

• July 15, 2021

Regulatory Expectations for Software as a Medical Device (SaMD) Startups

To ensure that products are safe and effective for use, medical device manufacturers need to follow specific guidelines enforced by the U.S. Food and ...

Medical Devices

• July 13, 2021

What is the Global Unique Device Identification Database (GUDID)?

The U.S. Food and Drug Administration (FDA) created the Global Unique Device Identification Database (GUDID) as a labeling resource for medical ...

• July 08, 2021

What's the Difference Between Biopharmaceutical vs. Pharmaceutical Startups?

Did you know that the biopharmaceutical industry represents some of the most significant achievements in modern science and technology? Listen to the ...

Medical Devices

• July 06, 2021

How to Get IEC 60601-1 Approval in 5 Easy Steps

For some medical device startups and scale-ups, achieving International Electrotechnical Commission (IEC) 60601-1 approval is easier said than done. ...

• July 01, 2021

3 Biopharmaceutical Manufacturing Trends to Watch in 2021

Since the advent of modern medicine, biopharmaceuticals have continued to revolutionize the treatment of both longstanding and emerging global ...

eHealth Technologies

• June 30, 2021

Advancing Human Health with Turnkey Biotech Incubator Brazen Bio

Subscribe on any major podcast player. Have you ever wondered why so many new biotech companies don't survive the first valley of death, which is the ...

• June 29, 2021

Qualio now offers industry-leading high availability

Reliable tools are a top priority for life sciences companies. When you’re bringing transformative new drugs, therapeutics, and medical devices to ...

Medical Devices

• June 29, 2021

The 13 Essentials of a Quality Plan for Medical Device Companies

A medical device quality plan is not only required by the FDA and the ISO 13485 framework, but it can help you build quality into your product and ...

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