The latest news and updates from cognidox

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 effectiv...

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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...

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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...

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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...

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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...

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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 ...

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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...

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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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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? ...

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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...

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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...

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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...

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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...

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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 maint...

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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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