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A short guide to non-conformance reports; what, why and how

How do you log and deal with non-conformities so that faulty products don't end up in the hands of customers? ...

6 min read

What does it take to make your TMF an eTMF?

A Trial Master File (TMF) is a comprehensive collection of documents that ensures the conduct of your clinical...

4 min read

Data integrity in life sciences: the vital role of ALCOA principles

Data integrity is central to the safe development and manufacturing of every life-science product on the marke...

5 min read

ISO 13485:2016: What does it take to meet medical device QMS requirements?

Navigating the complexities of ISO 13485:2016 can seem daunting, but understanding its requirements is crucial...

6 min read

Medical Device Technical File requirements: what you need to know

What is the medical device technical file? What should it contain and how should it be structured? And is it e...

6 min read

4 challenges you'll face moving from a paper based QMS to an eQMS

The case for ditching paper based QMS (Quality Management Systems) can seem like a no-brainer. But faced with ...

4 min read

What are the ICH Q10 Pharmaceutical Quality System guidelines?

In 2008, the ICH Q10 Pharmaceutical Quality System (PQS) guidelines introduced a comprehensive model for an ef...

5 min read

The eQMS low down: 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

IQ, OQ, PQ: what's needed for equipment validation in life sciences?

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

5 min read

Medical device audits: what, when, how and who?

Medical device audits can be a source of stress for developers and manufacturers. But what exactly are the aud...

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

UKCA Marking for Medical Devices: what's going on?

Post-Brexit there has been some confusion about the future use of UKCA (UK Conformity Assessed) markings and w...

4 min read

Managing the change control process for GxP compliance

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

4 min read

Chip design: Why a flexible eQMS is essential for semiconductor success

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

4 min read

How to manage clinical trials and meet GCP guidelines with Cognidox

Clinical research demands strict GCP (Good Clinical Practice) compliance. But many institutions stuck with out...

4 min read

QMSR and ISO 13485:2016: what’s in the new FDA regulation?

At last! It’s happened! The FDA has announced the date for the publication of its new Quality Management Syste...

5 min read

How to execute a seamless medical device design transfer process

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

3 min read

8 tips for documenting your SOPs (Standard Operating Procedures)

There are many reasons why organisations need to document their SOPs. From ensuring uniformity in end products...

4 min read

What's the best document control software for ISO 9001 & ISO 13485?

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

4 min read

Where are you on the Quality Management Maturity Grid?

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

3 min read

An A-Z of Medical Device Development; Acronyms, Regulatory & Technical Terms

The regulations and literature surrounding medical device development are packed with acronyms and technical t...

9 min read

Pros and cons of a phase gate process 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

Why not just use SharePoint 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

How's your Quality Management? Ad hoc, analytical or chaordic?

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

4 min read

Why not just use Dropbox as a document management system?

Dropbox is an easy to use cloud storage and sync application that is increasingly used in work settings for fi...

5 min read

QSR Compliance: What’s inside FDA 21 CFR Part 820?

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

5 min read

What are the 5 phases of medical device development?

The medical device development process is typically broken down into five distinct phases. Each one requires i...

5 min read

Corrective action: why, when and how?

It’s the job of your corrective action process to identify and eliminate the systemic issues that will prevent...

6 min read

Should you use Microsoft software to build your own digital QMS?

SMEs creating a digital Quality Management System (QMS) will often reach for the most familiar tools to build ...

5 min read

Calibration of equipment 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

Why not just use Google Drive as a Document Management System?

Google Drive is a cloud-based program that allows you to create, edit, store, and share documents. Many busine...

5 min read

Document Control requirements in ISO 9001:2015; what you need to know

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 in 4 simple steps

How do you transform regular supplier reviews from a box-ticking exercise into a genuinely useful commercial a...

6 min read

Why not just use SharePoint as a Document Management System?

What’s wrong with SharePoint, anyway? Why shouldn’t it be used as a document management system (DMS) for a gro...

5 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. What’s the difference?

ISO 9001 is the internationally recognised standard for quality management used in many sectors from construct...

4 min read

What is post-market surveillance for medical devices?

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 Improving the 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

Is that final? 5 reasons to use 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

MD, IVD, AIMD or SaMD? What is a medical device?

Question for you: what exactly is a medical device? Is the product you are developing a Medical Device, an In ...

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

What are the FDA's requirements for CAPA (Corrective And Preventive Action)

Having a repeatable procedure for Corrective and Preventive Action (CAPA) is a key FDA requirement for medical...

4 min read

What's the difference between a QMS, eQMS and an eDMS?

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

What is 21 CFR Part 11? FDA requirements explained

WTH is FDA 21 CFR Part 11? That’s a question many medical device developers wanting to access the US market mu...

5 min read

The evolution of a Quality Management System

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

4 min read

Why design controls matter in Medical Device Development

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

3 min read

The FDA submission process: 510K vs PMA. What’s the difference?

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

4 min read

Why not just use Qualio as 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

What are good documentation practices & how can they best be implemented?

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