The latest news and updates from cognidox

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 ...

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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...

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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...

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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...

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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...

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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 ...

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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 ...

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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 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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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...

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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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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...

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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...

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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 documentation...

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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...

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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...

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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...

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How to scale your medical device consultancy practice

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

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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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How can you get your FDA 510(k) submission right first time?

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

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Automotive chip shortages: Why chip shortages mean opportunities for fabless semiconductor companies

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

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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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7 risks you run migrating to a med dev eQMS and how to manage them

Migrating to a new eQMS is a big step for any medical device company, with many pitfalls for the unwary. What ...

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Chips with everything? Could you win big in the RISC-V revolution?

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

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What is a document control system and why is it important?

Having a document control system in place is a requirement of quality standards and regulations around the wor...

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Cognidox rolls out new training analytics and project cloning features in v10.2

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

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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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Document Management and Document Control: Is there a difference?

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

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Quality Control VS Quality Assurance. What is the difference?

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

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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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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 ...

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8 powerful benefits of a document management system

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

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What is an Electronic Document Management System (EDMS)?

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

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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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4 ways to build an ISO 13485 compliant medical device QMS

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

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10 reasons fabless semiconductor companies need a document control system

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

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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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Are you in control? Document lifecycle management software for ISO 9001 compliance

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

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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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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...

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QMS documentation requirements in ISO 13485

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

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What is document life cycle management & why does it matter?

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

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Take it from me: 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 ...

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Corrective actions: why, when and how?

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

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Document control in your medical device Quality Management System

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

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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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