Quality management resources

Best practice guides, webinars, product info and podcasts.
Created by and for life science quality professionals.

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All publications

Topic
Media
Toolkit
Medical Device

ISO 13485 toolkit

ISO 13485 is the definitive quality standard for organizations involved in the design, development and manufacture of medical devices. Download our ...
Guide
eQMS

Comparing the top quality management system vendors: G2 2022 report

Access our G2 Winter 2022 guide to learn:   What real eQMS software users think of the vendors and systems on the market The key criteria for ...
Guide
Pharmaceutical

The perfect quality assurance plan for pharmaceutical companies

Download our whitepaper to learn: The structure of a solid pharmaceutical quality manual The characteristics of the perfect pharmaceutical QA ...
Product Info
Medical Device

Medical device quality management software datasheet

Download our medical device quality management datasheet to learn how Qualio: Arms your business with a complete, compliant eQMS for medical device ...
Webinar
Regulatory

How to fund your life science start-up with non-dilutive funding

Watch this webinar to:   Gain knowledge about all relevant sources of funding for life science companies Learn about the process for applying ...
Webinar
eQMS

How to adapt to an eQMS with ease

Access our webinar recording to learn:   How to build a roadmap for a successful transition from a paper-based QMS to an electronic one How to avoid ...
Webinar
Medical Device

IVDR compliance: tips and best practice

Watch this webinar to:   Learn about the key requirements of the EU's In Vitro Diagnostic Regulation (IVDR) as it comes into effect Understand the ...
Guide
Medical Device

9 ways to improve quality in medical device product development

Download our guide to learn: The 9 things your business needs to do to maximize your medical device quality Common issues for medical device ...
Podcast

How to Maintain a Quality Culture during Explosive Growth

  Subscribe on any major podcast player. Today’s guest is Kristinn Gylfason, Compliance Officer at Sidekick Health and a lawyer who specializes in ...
Product Info
eQMS

Design controls management datasheet

Download our design controls management datasheet to learn how Qualio: Gives your business a concerted, compliant and accelerated route to market for ...
Podcast

Funding and Scaling your Med Device Startup with Jen Baird

  Subscribe on any major podcast player. Getting funding and scaling a medical device business alone is challenging. But challenges don't deter ...
Webinar
eQMS

Building compliance with an electronic quality management system (eQMS)

Watch this webinar to:   Understand the dramatic value and efficiency boosts that timely eQMS implementation unlocks Gain clarity on the myths and ...
Guide
Medical Device

Assembling a Design History File (DHF) for your medical device

Download our Design History File (DHF) guide to: Understand what a DHF is and how it fits into your medical device quality management activities The ...
Product Info
Medical Device

SaMD quality management software datasheet

Download our software as medical device (SaMD) quality management datasheet to learn how Qualio: Arms your business with a complete, compliant eQMS ...
Webinar
Quality

Mastering risks and opportunities: tips, tools & techniques

Watch our webinar recording to: Get actionable takeaways to strengthen your risk and opportunity management  Access tips, tools and techniques for a ...
Webinar
Regulatory

Passing an audit: pro tips from an expert QA panel

Watch our webinar and learn how to:   Answer auditors' questions with confidence Deal with findings collaboratively Align the quality team and the ...
Guide
Regulatory

FDA CFR Part 11 checklist

Download your FDA 21 CFR Part 11 checklist to:   Get to grips with the FDA's requirements for the integrity, quality and compliance of electronic ...
Podcast

Improving the State of Cell Isolation & Recovery with Andrew Breite from VitaCyte

  Subscribe on any major podcast player. Today's guest, Andrew Breite, Director of Quality at VitaCyte, discusses VitaCyte's contributions to cell ...
Guide
eQMS

Why cloud-powered quality is the future

Download our whitepaper to learn: Why more and more life science professionals are turning to cloud-based electronic quality systems The real ...
Podcast

Using AI to Improve Healthcare Outcomes and Access with Sam Dribin

  Subscribe on any major podcast player. Sam Dribin is the Chief Technology Officer for CureMetrix, an AI company focused on solutions that support ...
Webinar
Regulatory

Integrating data integrity requirements into your QMS

Watch this webinar to:   Understand how to embed data integrity by design into your business DNA Compare data integrity to data quality and ...
Webinar
Medical Device

Introducing Qualio Design Controls

Watch this webinar to learn:   How Qualio Design Controls eliminates silos between quality and engineering teams by absorbing data from Jira, Azure ...
Podcast

Quality Management Fundamentals in Aerospace and Life Sciences

  Subscribe on any major podcast player. Cables are everywhere, quite literally. Quality management for a cable testing company can be challenging, ...
Webinar
Quality

Quality trends report 2022: findings, challenges and plans for a quality management system for life sciences

Watch our webinar recording to:   Hear four quality experts discuss the findings from Qualio's global life science quality trends survey 2022 ...
Toolkit
Quality

Life science culture of quality toolkit

Download our life science culture of quality toolkit to learn: What a culture of quality looks like for medical device, pharmaceutical, biotech and ...
Webinar
Regulatory

Combination products: regulatory approach and cGMP requirements

Watch our webinar to learn:   cGMP requirements for the classification of drug-device combination products The common pitfalls drug companies face as ...
Guide
Regulatory

How to prepare for ISO 9001 certification

Download our ISO 9001:2015 guide to: Learn how to prepare for certification Take the first steps on your accreditation journey Understand the core ...
Webinar
Quality

What your quality management system needs for ISO and FDA regulation

Watch our webinar recording to:   Learn about the 12 pillars of quality management from experts with over 30 years of combined experience Understand ...
Product Info
Medical Device

EU MDR software datasheet

Download our EU MDR compliance software datasheet to learn how Qualio:   Arms your business with a complete, EU-compliant eQMS for medical device ...
Guide
Medical Device

Medical device classification guide

Download our medical device classification guide to: Understand what regulatory class your medical device falls under for FDA and EU compliance ...
Webinar
eQMS

How to maintain and improve your quality management system while working remotely

Watch this webinar to:   Learn how to manage, control and optimize your QMS activities from anywhere Access best practice and ideas from quality ...
Webinar
Medical Device

Reducing time and cost to market for medical devices

Watch this webinar to:   Gain a deeper understanding of each step of the journey to the medical device market  Learn from experienced professionals ...
Guide
Regulatory

Annex SL: the core of your ISO journey

Download our Annex SL guide to learn: How Annex SL forms the overarching 'high-level structure' governing all modern ISO standards The 10 clauses of ...
Guide
ISO 13485

How to prepare for ISO 13485 certification

Download our ISO 13485 certification preparation guide to: Understand the ISO 13485:2016 standard and its requirements Get to grips with what your ...
Toolkit
GxP

GxP toolkit

Whether your business operates a laboratory, clinic or pharmaceutical manufacturing line, GxP is essential. Download our GxP toolkit to: Understand ...
Toolkit
Pharmaceutical

ICH Q10 toolkit

Download our ICH Q10 toolkit to: Understand the fundamentals of ICH Q10, from the 4 lifecycle stages to the 4 pillars Take actionable steps towards ...
Product Info
eQMS

Integrations datasheet

Download our datasheet to learn how Qualio's integrations functionality: Connects your QMS to your other business-critical systems Breaks down ...
Guide
Quality

Life science quality trends report 2022

Download our trends report to learn: How hundreds of life science quality professionals do their work How they feel about management support, pay, ...
Podcast
eQMS

CureMetrix Helps Radiologists Make Better, Faster Decisions With AI

It’s no secret the pandemic kept many people at home for the bulk of the last year. At the same time, businesses that weren’t deemed essential were ...
Product Info
eQMS

Document management datasheet

Download our document management datasheet to learn how Qualio: Empowers your organization with a centralized digital repository of quality ...
Product Info
eQMS

Quality event management datasheet

Download our quality event management datasheet to learn how Qualio: Unlocks end-to-end control and visibility of all your quality events Drives ...
Webinar
Regulatory

Passing an MHRA inspection in the UK: pro tips from an expert QA panel

Watch this webinar recording to:   Prepare for and pass your upcoming MHRA inspection with flying colors Streamline and accelerate your MHRA approval ...
Guide
eQMS

12 questions to ask before you buy an eQMS

Access our guide to learn:   The 12 specific and detailed questions you should be asking eQMS vendors on your system hunt How to pinpoint the right ...
Product Info
eQMS

Contract organization quality management software datasheet

Download our contract organization quality software datasheet to learn how Qualio: Gives contract research and manufacturing organizations a trusted ...
Product Info
eQMS

Training management datasheet

Download our training management datasheet to learn how Qualio: Provides a robust and holistic training environment for life science companies Embeds ...
Product Info
eQMS

Qualio+ datasheet

Download your Qualio+ datasheet to:   Learn how our quality-as-a-service support accelerates and simplifies your compliance journey Explore our suite ...
Podcast

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

  Subscribe on any major podcast player. Today’s guest is Dr. Heather Underwood, CEO of EvoEndo. She talks about launching the first unsedated ...
Guide
eQMS

Audit readiness checklist

When it comes to preparing for your next audit, you want to check all the boxes. Use this comprehensive checklist to evaluate your organization’s ...
Guide
eQMS

Why your life science business needs electronic document management

Download our document management whitepaper to learn: Why more and more life science companies are embracing electronic document management How an ...
Podcast

Lessons from Building an Open Source Quality Community with Gill Berry

  Subscribe on any major podcast player. Gillian Berry is a qualified clinical nurse specialist and founder of PerCen Technologies. She founded ...
Guide
Regulatory

How to respond to an FDA 483 letter

In this guide, we show you how to respond quickly and effectively to a 483 letter and get back to developing products. The FDA does not want to ...
Webinar
eQMS

Culture of quality webinar

Access our webinar recording to:   Learn what a culture of quality really is Unpick what a healthy quality culture and its consequences look like ...
Podcast
Medical Device

Expanding Med Device Distribution Internationally and in China

Subscribe on any major podcast player. Andy Levien, President and CEO of ArcScan talks to Robert about expanding his medical device company ...
Product Info
eQMS

The return on investment of an electronic quality management system (eQMS)

Download our eQMS return on investment breakdown guide to: Understand the typical cost savings associated with an electronic quality management ...
Product Info
Pharmaceutical

Pharmaceutical quality management software datasheet

Download our pharmaceutical quality management datasheet to learn how Qualio: Arms your business with a complete, compliant eQMS for pharmaceutical ...
Product Info
eQMS

Supplier management datasheet

Download our supplier management datasheet to learn how Qualio: Gives your business unshakeable control of your third-party relationships Equips your ...
Guide
Medical Device

Ultimate guide to medical device design controls

Download our ultimate design controls breakdown guide to: Become an expert in medical device design controls Get to grips with design control ...
Guide
Medical Device

EU MDR general safety and performance requirements (GSPR) checklist

Download our EU MDR general safety and performance requirements (GSPR) checklist to:   Understand every requirement your business and device(s) must ...
Guide
Medical Device

Audit readiness checklist for medical device companies

You know you want to be ready for the next audit, but how do you prepare? Use this complete checklist to evaluate your medical device company’s audit ...
Guide
ISO 13485

ISO 13485 risk management plan template

Download our ISO 13485 risk management plan template to: Access a ready-made 8-section template of a typical ISO 13485 risk management plan ...
Guide
eQMS

How to evolve to a paperless eQMS

Access our guide to learn: The 3-step migration journey from paper to an electronic quality management system (eQMS) Top tips and recommendations for ...
Podcast

Defining Quality: The Role, Responsibilities, and Industry

  Subscribe on any major podcast player. Today we're excited to have Laura Araujo, Vice President of Quality at 4G Clinical share her insight into ...