The latest news and updates from cognidox

Medical Device, IVD or SaMD? Medical device regulation explained

  Question for you: is the product you intend to develop a Medical Device, an In Vitro Diagnostic Medical Devi...

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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...

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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) ...

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DHF, DMR and DHR. Demystifying FDA medical device development requirements

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

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What's a Device Master Record (DMR)? What’s the best way to compile it?

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

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Implementing Medical Device Design Controls for ISO 13485 and FDA 21 CFR 820

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

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Is it possible? Lean Document control procedures in the life science sector

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

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Why not just use Dropbox for your Medical Device QMS?

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

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11 'must have' features of medical device document control software

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

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What’s the cost of chaos in a document management system?

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

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Why not just use Google Drive for your medical device QMS?

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

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Moving from paper to a digital medical device Quality Management System

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

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How to stop ‘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...

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What is a UK Responsible Person (according to the MHRA)?

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

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Understanding the regulation: challenges for UK IVD device developers

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

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How to develop a medical device; the 5 phases of med-tech development

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

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Life after Covid-19 for the IVD (in vitro diagnostics) industry

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

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EU IVDR (In Vitro Diagnostics Regulation): Time’s running out to comply

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

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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 ...

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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...

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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...

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Process verification vs process validation for medical devices

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

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Bionic pigs are not enough. How to win med-tech investment if you're not Elon Musk

When Elon Musk unveiled his ‘bionic pig’ in an on-line event in September there was much hype and more than a ...

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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...

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What Is cGxP?

cGxP (also known simply as GxP) is an acronym used by the FDA and other regulators within the life science ind...

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Are Life Science Companies The New ‘Wildcatters’?

Research shows one of the key challenges for life science companies is balancing the need for rapid innovation...

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Post Market Surveillance for Medical Devices; Why, How & Who?

Post Market Surveillance (PMS) has been elevated in importance by the new MDR and IVDR regulations which will ...

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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...

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Good Distribution Practices (GDP) In the Pharmaceutical Industry

Managing the quality of medical products as they are stored and distributed brings with it many challenges. Di...

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What are the IVDR and MDR requirements for Economic Operators

There are four entities defined under the EU MDR and IVDR as “economic operators”. Under the regulation, these...

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Digital Signatures: New MHRA guide clarifies remote approval requirements

A lot of us have been challenged by remote working lately, whether it’s the back ache acquired from working on...

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Compiling a Design History File (DHF) for a medical device product

For medical device developers assembling and presenting all the required documentation for the DHF (Design His...

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What's new for medical device manufacturers in iso 14971:2019?

The third edition of ISO 14971 (Application of Risk Management to Medical Devices) was released in December 20...

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What do you really need for successful medical device development?

There’s no shortage of words in print and online written by regulators, consultants and software developers ab...

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Med Tech: where to start - Product development or document management?

What should come first in a med tech project? Product development or documentation? 

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MDSW, IVDR, MDR and the new guidance from the EU

As the 2020 deadline for compliance with the EU’s new Medical Device Regulation (MDR) fast approaches, the EC’...

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GAMP 5 ®: How to take a risk-based approach to GP computerised systems

The Good Automated Manufacturing Practice (GAMP 5 ®) guidelines define a set of core principles for GxP, as pr...

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New IVD regulation is coming. are you ready?

From 2022 the In Vitro Diagnostics Regulation (IVDR) will require Notified Body intervention and review for 80...

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How to avoid the med tech graveyard with user centred design

A med tech device that has a poor user experience can be dangerous for consumers and commercially calamitous f...

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Why design controls matter in Medical Device Development

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

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Are you developing a medical device?

Are you developing a medical device? And are you certain about that? It might sound like a crazy question. If ...

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