Robert Fenton

Robert FentonMar 13, 2024

How to choose ISO 13485 QMS software in 2026

Learn how to evaluate the best ISO 13485 compliant software for quality management system compliance and at your medical device company.

Biotech

6 strategies for successful biotech funding

Biotech founders use funding strategies like venture capital, grant applications and research partnerships. Learn more about biotech funding strategies.

Robert FentonNov 8, 2023

Robert FentonFeb 24, 2023

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

Discover the key differences in scope, significance and application between the ISO 13485 and ISO 9001 quality standards for medical devices.

Company news

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

Qualio donates 1% of our annual revenue to improving healthcare access for vulnerable populations for the 2nd year in a row.

Robert FentonJan 19, 2023

Quality management

5 tips for quality management compliance

Worried about your quality and compliance? We show you how to ensure your quality management system is tip-top, compliant and audit-ready.

Robert FentonJan 18, 2023

Company news

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

Company awards, product evolution, and a tenth birthday! As the year draws to an end, our CEO Rob Fenton looks back on a successful 2022 at Qualio.

Robert FentonDec 15, 2022

Robert FentonAug 16, 2022

How to start a pharmaceutical company

Find out what you need to start a pharma company. Learn how to get funding for your pharma startup, set up your quality management system and more.

Biotech

6 biotech incubators for startups in the U.S.

Find a local biotech incubator to help your life science startup get off the ground. Here are 6 firms to consider for your early-stage biotech company.

Robert FentonJun 30, 2022

Culture

Qualio: officially Best Place To Work!

We're thrilled to announce that Qualio has been officially named in Inc. Magazine's Best Workplaces of 2022!

Robert FentonMay 10, 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....

Robert FentonApr 6, 2022

Robert FentonJan 17, 2022

The 4 Best Medical Device Quality Assurance Training Options

Medical device quality assurance training can give your team the knowledge and confidence to move your company to the top of your industry.

Company news

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

Qualio donates 1% of our annual revenue to improving healthcare access for vulnerable populations for the 2nd year in a row.

Robert FentonDec 22, 2021

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

How do you foster continuous improvement in quality management for a life sciences company? Here are 4 examples of continuous improvement from which you can...

Robert FentonSep 9, 2021

Rapidly Discovering and Extracting Natural Pharmaceuticals

Mental health issues have been on the minds of many as athletes are under tremendous pressure to perform perfectly at the Olympics.

Robert FentonAug 5, 2021

Robert FentonJul 27, 2021

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

Learn more about the FDA medical device approval process timeline and how you can ensure that your company won't run out of money before you start...

Robert FentonJun 16, 2021

Launching the First Single-use Endoscope for Unsedated Pediatric Endoscopy with Dr. Heather Underwood, CEO of EvoEndo

Today’s guest on the podcast is Dr. Heather Underwood, CEO of EvoEndo. She talks about launching the first unsedated single-use endoscope to market.

$50M Series B led by Tiger Global Management

Updates

Announcing Qualio's $50M Series B Funding Round

Today, we get to celebrate another milestone. Qualio has raised a $50M Series B led by Tiger Global. Learn more about...

Robert FentonMay 25, 2021

Robert FentonMar 17, 2021

How to Get Non-Dilutive Funding via Federal Agencies

Over $50B (with a B!) is available each year to life science companies from federal agencies. The best part is, it's all non-dilutive funding.

What are the best pharmaceutical quality assurance courses online?

Learn about the best pharmaceutical quality assurance courses online and how continuing education is important for quality assurance and quality control professionals in pharmaceuticals.

Robert FentonMar 9, 2021

Document Control

How A Document Control System Can Transform Your Business [7 Benefits]

Learn what a document control system is, how it can transform your business, which benefits it offers, and what features to look for.

Robert FentonMar 4, 2021

Robert FentonDec 22, 2020

5 Essential Elements of Quality Management Software

Not all quality management software is created equal. These are the five essential elements that...

Updates

Improving Healthcare Access for Vulnerable Populations

Starting this year, Qualio will donate 1% of our annual revenue to improving healthcare access for vulnerable populations.

Robert FentonDec 22, 2020

Robert FentonDec 16, 2020

From Hippie to Med School to Entrepreneur with Dr. Hana, MD

Dr. Hana Solomon, MD shares her journey from hippie to single-mother to med school to entrepreneur. She's the founder of BeWell Health and inventor of Nasopure, the most comfortable nose wash in the world. She shares her wisdom to avoid "stupid business mistakes" such as acquiring the right type of

Robert FentonNov 10, 2020

Does an FDA Class 1 Medical Device List Exist?

Learn about the pathway to approval if your product can be classified as a Class 1 medical device.

Robert FentonOct 20, 2020

What Are the Objectives [5 Examples] of Quality Assurance in the Pharmaceutical Industry?

Learn about the 5 critical objectives of quality assurance in the pharmaceutical industry. If you don't want to fall behind the competition, you need to ensure...

FDA

FDA to Issue New Guidance on QMS Validation: 4 Major Changes

The FDA plans to issue new guidance on QMS validation. Here are some of the changes that we...

Robert FentonOct 15, 2020

Robert FentonOct 13, 2020

5 Major IEC 62304 Compliance Mistakes Medical Software Manufacturers Make

IEC 63204 compliance is a functional safety standard that applies to medical device development and maintenance. We've found that most...

The ISO 13485 Checklist for Medical Device Manufacturers

Are you preparing for ISO 13485 certification? Consult this helpful ISO 13485 checklist so that you can streamline certification and...

Robert FentonOct 8, 2020

Robert FentonSep 24, 2020

Understanding Risk Classification of Medical Devices: 3 Major Grades

The FDA CDRH risk classification is based on the risk associated with your medical device. There are three risk classifications of medical devices including...

Robert FentonSep 10, 2020

The 5 Best Medical Device Product Lifecycle Management Tools

Let's look at the best medical device product lifecycle management (PLM) options to determine which will help you avoid big problems and...

Robert FentonAug 27, 2020

What is eQMS Software Validation?

In the medical device industry, eQMS software validation is a required step in the onboarding process. You might not know that when...

Robert FentonSep 3, 2020

FDA

What Are The Top FDA Software Validation Requirements? [Review]

Learn about the FDA and its current guidance on General Principles of Software Validation and how it has changed since its initial release date in 2002.

Robert FentonSep 1, 2020

Business

Top 7 Biotech Investors Changing the Life Science Industry

Is your biotech company trying to raise a new funding round? These amazing biotech investors have...

Robert FentonAug 25, 2020

5 Essential Elements of a QMS for Medical Devices

Finding the right QMS system for medical devices can be a challenge. You need to prioritize these core elements including...

Robert FentonAug 11, 2020

4 FDA Medical Device Reporting Procedures for Life Science Companies

What are the FDA medical device reporting procedures that you need to know about. The following...

Medical Device Risk Management

An ISO 13485 Risk Management Plan Example You Can Steal and Use

There are times when creativity is a good thing, but putting together an ISO 13485 risk management plan isn't one of them.

Robert FentonJul 21, 2020

Certification

How to Get a Quality Management Certification in 5 Simple Steps

Getting a quality management certification can feel overwhelming. Follow these simple steps to...

Robert FentonJul 2, 2020

Robert FentonJun 30, 2020

5 Essential Tasks to Include in Your EU MDR Checklist

As you prepare for EU MDR, what are the tasks that you should absolutely include in your readiness checklist? We've found...

Robert FentonJun 25, 2020

The 5 Best ISO 14971 Training Programs

ISO 14971 is an ISO standard for the application of risk management for medical devices. Here are the best ISO 14971 training programs to...

Robert FentonJun 18, 2020

5 Online Medical Device Design Control Templates

Don't let design controls trip you up. Pick one of these five medical device design control templates to speed up your design process and ensure...

Robert FentonMay 14, 2020

5 Pharmaceutical Manufacturing and Quality Management Trends

Is your pharmaceutical manufacturing company struggling to stay ahead of the curve?

Robert FentonApr 15, 2020

How to Set Up an ISO 14971 Risk Matrix in 5 Simple Steps

We'll show you how to set up your own ISO 14971 risk matrix in just a few steps to give your company confidence and consistency and keep your organization...

Robert FentonMar 12, 2020

6 Best Practices from Six Sigma that Medical Device Companies Should Follow

Ready to make your medical device business better? Check out the six best practices of Six Sigma medical device companies that you should implement to get

Design Controls for a Medical Device: 5 Secrets for Success

Need expert advice on design controls for a medical device? With these five secrets, you'll be able to document insights that lead to profitable...

Robert FentonMar 3, 2020

Robert FentonFeb 27, 2020

7 ISO 13485:2016 Changes That Can Make Your Company Better

Has your medical device company lost its competitive edge? We've identified seven specific ISO 13485:2016 changes and how you can...

Robert FentonFeb 11, 2020

Medical Device Consultant Rates for 2020: What You Should Get for Your Investment

Medical device consultant rates fluctuate along with changes in the medical field. There are 5 things to know about consultant rates so you don't risk ...

Robert FentonJan 30, 2020

Reviewing the Best Medical Device Risk Management Consultant Options for 2020

A medical device risk management consultant can help reduce your anxiety and ensure that every single one of the products that leave your facility will...

Medical Device Compliance Consulting: 11 Questions to Ask Before Hiring

Working with a great medical device compliance consulting firm could keep you on the good side of regulatory bodies & ensure that your organization does not...

Robert FentonJan 7, 2020

Robert FentonDec 24, 2019

How Much Does Medical Device Regulatory Consulting Cost in 2020?

How much do medical device regulatory consulting firms charge? That's the first question to ask when trying to...

Robert FentonDec 10, 2019

5 Staggering Medical Device Recall Statistics That Should Concern Everyone

Faulty medical devices can have catastrophic consequences! These alarming medical device recall statistics should cause you to lose sleep—unless you have...

Robert FentonNov 27, 2019

6 Signs Your Quality Management Process Is Failing

Is your company vulnerable to recalls, reputational damage, and regulatory issues because of quality management process problems? We'll show you five...

Robert FentonNov 19, 2019

5 Common Medical Device Regulatory Compliance Problems Faced in 2020

These 5 medical device regulatory compliance problems can kill life sciences companies. If you're making these errors, make an adjustment now, before you...

Robert FentonNov 14, 2019

The Top 4 ISO 13485 Gap Analysis Templates: Pros and Cons

We've reviewed the best ISO 13485 gap analysis templates to help you pick the right one so that you can close the gaps and make substantial...

Robert FentonNov 12, 2019

The Quality Policy of Pharmaceutical Industry Leaders Includes These 5 Things

The quality policies of pharmaceutical industry leaders are clear, simple, and distributed widely. By learning from them, you can ensure that your team...

How to Shrink the FDA Medical Device Approval Timeline

What kind of difference would it make if you could shave 30 days off the FDA medical device approval timeline? For some companies, it could mean...

Robert FentonNov 7, 2019

Robert FentonOct 31, 2019

How to Pass Every Quality Management Audit Without Breaking a Sweat

Don't let a quality management audit scare you to death. Implementing these 7 preparations will position you to pass the next audit without any of the...

Robert FentonOct 24, 2019

How to Solve 5 Common Document Control Procedure Problems

Is document control giving you a migraine? Let's look at the most common document control procedure problems and how to avoid them so that your team can...

Robert FentonOct 17, 2019

Preclinical Testing of Medical Devices: 7 Essential Steps to Prepare

By preparing well for preclinical testing of medical devices, you'll pass this important step with flying colors, impressing 3rd-party reviewers and securing...

Robert FentonOct 15, 2019

5 Medical Device Compliance Problems That Can Permanently Damage Life Sciences Companies

By dodging some of the most common medical device compliance problems, you can not only ensure you pass the regulations, but safeguard your company from...

Robert FentonSep 26, 2019

The 4 Worst Supplier Quality Management Procedure Problems for Life Sciences Organizations

Supplier quality management procedure problems can sink your company in a hurry. Ignorance of these issues is dangerous. We've put together this list so you...

Robert FentonSep 12, 2019

The 6 Best Medical Device Regulatory Consulting Services in 2020

Looking for the best medical device regulatory consulting services? These 6 consultancy firms have the experience to help you solve difficult challenges with...

9 Helpful Document Control Tips You Can Implement Right Now

Here are 9 document control tips guaranteed to make quality management in your company better. Implement these best practices and you'll get ...

Robert FentonSep 5, 2019

Robert FentonAug 27, 2019

ISO Compliance: The What, Why, and How for Life Sciences Companies

What is ISO compliance? Click through to learn what it is, why it exists, and how to make it benefit your company without ever losing a....

Robert FentonJul 30, 2019

9 Ways Canadian Medical Device Regulations Differ From the US

Considering expanding your medical device sales to Canada? Is passing Canadian regulations going to be too big of a pain to make it worth it?

Paper-Based

What's the Best Corrective Action Database Software?

Do you view corrective action systems as a necessary evil or an opportunity to become the best?

Robert FentonJul 23, 2019

Robert FentonJul 18, 2019

Product Realization ISO 13485 In Layman's Terms

What are the salient points of the ISO 13485 product realization guidelines?

Robert FentonJul 16, 2019

4 Regulations That Apply to Medical Device CRO Selection

How can you make sure that you're selecting the right contract research organization (CRO) for your medical device?

Robert FentonJul 11, 2019

The Pros and Cons of Medical Device Consulting

Will using medical device consulting services be a net positive for your business, or would you be better off spending the money elsewhere?

Robert FentonJun 27, 2019

The EU Med Device Regulation Timeline: What You Should Know in 2020

The EU has designated a transition period from the decades-old Medical Device Directive to the new Medical Device Regulation which ends in May of 2020.

Robert FentonJun 25, 2019

Evaluating Contract Sales Organizations for Medical Device Companies

If your medical device company has hit a sales slump, a contract sales organization can be the solution to get you back on track.

Robert FentonJun 20, 2019

Which Conformity Assessment Should Med Device Companies Choose

Choosing the right conformity assessment for your medical device company will ensure you get approval without wasting resources.

Who’s the Best FDA Consultant for Medical Device Manufacturers?

Worried that passing FDA regulations for your medical device is going to slow time-to-market and cause your team massive headaches?

Robert FentonJun 4, 2019

Robert FentonMay 28, 2019

The Essential Parts of an ISO 13485 Medical Device QMS

Using a QMS specifically designed for ISO 13485 is a smart move, but how do you know when you've found a good one? Look for features like ...

Quality vs. Compliance: These 5 Questions Will Determine Your Focus

Learn about the main differences between Quality vs. compliance. They're both necessary components to product development, but as an organization, it's critical to understand the differences.

Robert FentonApr 9, 2019

Robert FentonMar 28, 2019

What Are The 4 Reasons You Need An Agile QMS? (And The Easiest Way to Get One)

Learn how an effective eQMS provides the right balance of structure and flexibility to achieve organizational agility.

Robert FentonMar 26, 2019

What An ISO 13485 Quality Manual For Medical Devices Should Look Like

The quality manual for medical devices is a document required by ISO 13485, a quality management system designed for medical device manufacturers.

Paper-Based

The Top 5 Cloud-Based Quality Management System Options for 2020

It's important to compare a few eQMS options, as every company that requires a cloud-based QMS is different, with varying expectations and needs.

Robert FentonFeb 14, 2019

Robert FentonJan 29, 2019

How to Achieve Effective Quality Assurance

An effective QMS can create clarity in a difficult circumstance, while a needlessly over-engineered QMS can damage project results.

Robert FentonDec 18, 2018

Essential Tools to Achieve Compliance in the Pharmaceutical Industry

What are the essential tools you need for regulatory compliance in the pharmaceutical industry?