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Understanding QMS, eQMS, and eDMS for Quality Management Success

There are different ways companies can build required quality management systems, from using traditional paper...

5 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

Navigating FDA Approval: Understanding 510K vs PMA

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

Tips for a Successful FDA 510(k) Submission: Get It Right

Developers who want to release a medical device in the US need to seek permission from the FDA. Depending on t...

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

Understanding Document Management vs Document Control

For some companies simply managing their documentation is enough to support their business goals. But others n...

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

Understanding Electronic Document Management Systems (EDMS)

An Electronic Document Management System (EDMS) is a software that centrally stores and organises documentatio...

5 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

10 Reasons Fabless Semiconductor Companies Need Document Control

With complexity and costs rising, fabless semiconductor companies need to do all they can to keep their flow a...

6 min read

Is Dropbox Suitable for Your Medical Device QMS?

DropBox is a file sharing platform familiar to millions throughout the world. Once a personal file storage and...

5 min read

11 Essential Features of Medical Device Document Control Software

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

5 min read

Mastering Document Lifecycle Management for ISO 9001 Compliance

ISO 9001 requires you to control the document lifecycle to improve the efficiency and effectiveness of your bu...

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

Is Google Drive Suitable for Your Medical Device QMS?

A Quality Management System is a requirement for medical device developers across the globe. But should you bu...

5 min read

Structure Your QMS Documentation for ISO 13485 Compliance

How should you structure your documentation to meet the requirements of ISO 13485?

4 min read

Understanding the Importance of Document Lifecycle Management

What are the 7 stages of the document lifecycle? Why is managing and controlling the lifecycle a critical part...

5 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

Mastering Document Control in Your Medical Device QMS

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

5 min read

How to Prevent Over-Processing in Your Medical Device QMS

Building a quality management system is never a quick and simple process. But in medical device development, w...

4 min read

Understanding the UK Responsible Person Requirement Post-Brexit

Following Britain’s exit from the EU, all non-UK medical device and IVD manufacturers who want to place their ...

4 min read

Navigating IVD Device Regulations in the UK: Challenges for Developers

IVD device regulation is about upping the bar—it’s about making products to a higher standard and ensuring the...

4 min read

Mastering ISO 9001:2015 Quality Principles - A Guide to Implementation

ISO 9001:2015 and its related quality standards are all based on the ‘Seven Quality Management Principles’ def...

3 min read

Navigating the Post-Covid Landscape: The Future of the IVD Industry

The Covid pandemic has brought new attention, investment and competition to the IVD sector. But with new oppor...

4 min read

Navigating EU IVDR Compliance: Key Changes and Deadlines

The EU In Vitro Diagnostics Regulation (IVDR), written in 2017, was developed to replace the existing EU In Vi...

3 min read

8 Essential GMP Principles for Med Tech Developers

Good Manufacturing Practices (GMP) are intended to ensure that pharmaceutical products, medical devices and ot...

4 min read

The Power of Design Reviews: Preventing Costly Mistakes

I worked in one of the large Cambridge-based technology consultancies for many years and was privileged to hav...

3 min read

The Importance of a Quality Strategy for Your Company

I believe that a quality strategy is a vital element to the success of a business. Quality of product and oper...

3 min read

11 myths about ISO 9001 - busted!

Mention ISO 9001 to most people, or tell them that you implement quality systems, and they'll start glazing ov...

3 min read

The Pros and Cons of Virtual Collaboration for Product Innovation

Colocation was one of the central tenets of the Agile manifesto, but times have changed. With all the new digi...

5 min read

7 Key FDA E-Signature Requirements for Medical Device Developers

How does your organisation authorise, authenticate, document and police the use of electronic signatures withi...

4 min read

The Power of eQMS: Elevating Your Quality Management System

If you want to develop a Quality Management System that meets the regulation and powers your commercial succes...

4 min read

12 Virtual Team Collaboration Tool Issues to Address

As your computer waits to load up Teams, Zoom, Slack, Accello and countless other collaboration apps every mor...

3 min read

The Art of Accidental Innovation: Tales of Discovery and Success

Can product innovation really happen by accident? Penicillin, Viagra and the humble Post-It note were all famo...

4 min read

Embodying Lean Principles in Your Document Management System

Does your Document Management System (DMS) apply the five Lean principles to the way you work?

3 min read

7 Common Mistakes in Business Process Modelling Projects

Companies often embark on business process modelling projects with the best of intentions. Modelling may be a ...

3 min read

Securing Virtual Collaboration: Risks and Solutions

Last year, Slack, Zoom and countless other companies hoovered up business as companies shifted to support new ...

3 min read

Navigating Virtual ISO 9001 Audits: A Guide for Success

For those who need ISO 9001:2015 certification, virtual audits are currently taking the place of face to face ...

4 min read

Understanding Process Verification vs Validation for Medical Devices

Process verification and validation should be a key part of a medical device manufacturer’s QMS. But what’s th...

3 min read

Supporting Product Innovation with Document Control Software: The Key to Success

In the history of product innovation, stories of happy accidents abound. The list of inventions stumbled upon ...

4 min read

Maximising Remote Collaboration for New Product Development

Remote collaboration is the new normal and set to be a major feature of the post-Covid world. Workers have fou...

4 min read