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Comparing eQMS Solutions: Qualio Vs Cognidox

Cognidox and Qualio are both digital quality management systems (QMS) with a focus on the life science and med...

4 min read

Design verification and design validation for medical device developers

In medical device development, two critical stages of the design process are often confused: design verificati...

6 min read

MDSAP 101: An Introduction to the Medical Device Single Audit Programme

What if you could gain approval to sell your medical devices anywhere in the world, by completing a single, re...

3 min read

What’s the Cost of Quality? Can it really be free?

What’s the cost of quality? Can it, like QM guru Philip Crosby argued, really be free? Like most things in bus...

4 min read

Equipment Validation in Life Sciences: A Comprehensive Guide

Controlling and documenting IQ, OQ and PQ effectively is a complex and time-consuming process for life science...

5 min read

Cognidox announces new e-signature integration with DocuSign

Cognidox are delighted to announce the release of our new DocuSign e-signature integration. The new plug in is...

2 min read

Effective GxP Compliance: Managing Change Control

Change control in life science development is critical to ensuring the safety of patients. Having a formal pro...

4 min read

The Importance of Flexible eQMS in Semiconductor Success

Chip designs are becoming more complex and expensive to develop, verify and validate. Opportunities for fables...

4 min read

FDA Regulation Update: QMSR and ISO 13485:2016 Explained

In February 2024, the FDA published its final rule for the new Quality Management System Regulation (QMSR). So...

5 min read

Streamlining Medical Device Design Transfer: Key Steps for Success

Transferring design to production is a process that can be fraught with risk for medical device developers. Ho...

3 min read

How to Write Effective SOPs: 8 Tips for ISO and QMS Compliance

Writing clear, compliant Standard Operating Procedures (SOPs) is key to quality management in regulated indust...

5 min read

Document Control Software for ISO 9001 & ISO 13485: A Guide

There’s plenty of document management and file-sharing software available on the market, but not all of it is ...

4 min read

Quality Management Maturity Grid: A Roadmap to Excellence

Of all the quality management ‘gurus’, the late Philip Crosby is one of the most readable. In his book ‘Qualit...

3 min read

The Pros and Cons of Phase Gate Processes in New Product Development

Will a phase gate process hold back or enhance your new product development? What are the pros and cons of sta...

5 min read

Is SharePoint the Right Choice for Your Medical Device QMS?

A Quality Management System (QMS) is a requirement for medical device developers across the globe. But should ...

4 min read

Evolving Quality Management: From Ad Hoc to Chaordic

How can you help your business evolve its mindset to achieve the most instinctive, frictionless and effective ...

4 min read

Can Dropbox Be Used as a Document Management System (DMS) or eQMS?

If you’re a tech start-up or growing SME looking to implement an enterprise-grade file-sharing solution and co...

5 min read

Demystifying FDA 21 CFR Part 820: A Comprehensive Guide

The FDA’s Quality System Regulation (QSR) for medical device manufacturers is commonly known as FDA 21 CFR Par...

5 min read

The Importance of Equipment Calibration in ISO 13485 and ISO 9001

Monitoring and measuring quality of products and services is a key part of any QMS. But how can you be sure th...

4 min read

Understanding Document Control in ISO 9001:2015

Document control is a key part of any Quality Management System (QMS) and, therefore, a requirement of ISO 900...

4 min read

How to Build a Supplier Quality Management System (SQMS) in 4 Steps

Supplier Quality Management (SQM) is critical for ISO 9001, ISO 13485, and FDA compliance—but many organisatio...

6 min read

How is Software as a Medical device (SaMD) regulated by the FDA?

Does the fertility tracking app you are developing count as a medical device? What about the imaging software ...

5 min read

ISO 9001 vs ISO 13485: Key Differences and Implementation Tips

ISO 9001 and ISO 13485 are both internationally recognised quality standards, but they serve different industr...

4 min read

Understanding Post-Market Surveillance for Medical Devices in the EU

The PIP scandal, in which thousands of women were injured by faulty breast implants over a period of twenty ye...

4 min read

8 Tips for Streamlining Your Document Review Process

How is the quality of your document review process affecting the speed and efficiency of the way you do busine...

3 min read

5 Reasons Why You Need Document Version Control Software

We’ve all been there. We’ve lovingly put the final touches to that important document and saved it to the shar...

3 min read

Understanding Medical Device Classifications: MD, IVD, AIMD, or SaMD?

When developing a healthcare product, it's crucial to determine its classification: Medical Device (MD), In Vi...

5 min read

What’s the plan? A seamless product realisation process for ISO 13485

So, you’ve had your brilliant idea. You know what kind of medical device you want to build. You have a vision ...

4 min read

Compiling a design & development plan for your medical device

What are the planning requirements for a medical device design and development process? And what tools can hel...

5 min read

The Evolution of Quality Management Systems: A Path to Business Growth

A focus on a quality management system shouldn’t just mean a ‘box ticking’ exercise for an organisation. And i...

4 min read

The Importance of Design Controls in Medical Device Development

When it comes to medical device development, the absence of comprehensive design and development documentation...

3 min read

FDA 510(k) vs PMA: What’s the Best Path for Your Device?

How can medical device developers gain FDA approval for their devices and permission to sell their product int...

4 min read

Is Qualio the Right Choice for Your Medical Device eQMS?

Qualio is an eQMS platform launched in 2012 by Irish entrepreneur Robert Fenton. From small beginnings, his co...

5 min read

Best Practices for Good Documentation in Regulated Industries

Good documentation practices (also known as GdocP or GDP) are guidelines for document management and control d...

4 min read

How to scale your medical device consultancy practice

Many medical device consultancy practices work on a fee-based model, helping clients with regulatory and quali...

4 min read

How a QMS supports medical device risk management in ISO 13485

A QMS should ultimately help guard against customer harm or dissatisfaction, by guarding against the risk of f...

4 min read

FDA 510(k) Submission Tips for Medical Device Developers

To launch a medical device in the US, developers must gain FDA permission. For most Class II devices, this inv...

4 min read

Navigating the Automotive Chip Shortage

The semiconductor shortage continues to ravage many sectors. With its reliance on electronics for driverless t...

4 min read

Why not use greenlight guru as your med tech eQMS?

Greenlight Guru has been marketed since 2013 as the first digital eQMS (electronic Quality Management System) ...

4 min read

The RISC-V Revolution: Winning Big in the Chip Innovation Era

The rise of RISC-V seems inexorable. It’s being touted as an answer to the drastic slowing of Moore’s law. It’...

4 min read

Cognidox Unveils Exciting New Features in v10.2 Release

Cambridge, UK, 3 May 2022: Cognidox, a leading provider of document management solutions for the high-tech, me...

1 min read

Understanding FDA Medical Device Development Requirements: DHF, DMR, DHR

DHF, DMR, DHR… to the uninitiated they might sound like out-of-town furniture stores or airport codes for exot...

4 min read

Quality Control vs Quality Assurance: Understanding the Differences

QC is about detecting defects in your finished product, while QA is about preventing the defects from occurrin...

4 min read

The Ultimate Guide to Building a Device Master Record (DMR)

The Device Master Record (DMR) is one of the ‘holy trinity’ of files that developers need to collate and maint...

4 min read

Streamlining Medical Device Design Controls for FDA and ISO Compliance

30 years ago the FDA introduced robust new requirements for medical device design control following a string o...

5 min read

8 Key Benefits of a Document Management System

A document management system (DMS) is a method of managing, storing and retrieving all the documentation a bus...

4 min read

Effective Lean Document Control in Life Science Sector

In medical device development, document controls are the building blocks of an ISO and FDA compliant Quality M...

5 min read

Building an ISO 13485 Compliant QMS: 4 Effective Strategies

Are you looking for ways to build and maintain the most efficient, ISO 13485 compliant QMS as your company con...

4 min read

Is Dropbox a Compliant QMS for Medical Device Companies?

DropBox is a well-known cloud storage and file-sharing platform. Its sleek interface and seamless collaboratio...

5 min read

Medical Device Document Control Software: 11 Must-Have Features

Inflexible SOPs, complicated interfaces, training and maintenance requirements. Traditional document control s...

5 min read

How to Manage the Document Lifecycle for ISO 9001 Compliance

Managing your document lifecycle is central to achieving ISO 9001 compliance. This guide explains how to struc...

1 min read

The Cost of Chaos in Document Management: A Financial Wake-Up Call

Chaotic document management is wasting the time and energy of businesses around the world every year. But in s...

3 min read

Why Your Medical Device Start-Up Needs a Lean eQMS

In this blog, Shaun Knights, Head of Quality at period care company Callaly, tells us why his start-up needed ...

5 min read

Document Control: Ensuring Compliance with ISO 13485 & FDA Regulations

Document controls are a fundamental requirement of every medical device regulatory regime. They are the ‘build...

5 min read

Stop Over-Processing in Your Medical Device QMS

Building an effective Quality Management System (QMS) for medical device development is rarely quick or simple...

4 min read