The latest news and updates from cognidox

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

Why not just use Dropbox as a document management system?

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

What are the 5 phases of medical device development?

Corrective action: why, when and how?

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

Calibration of equipment in ISO 13485 and ISO 9001

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

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

Medical Device Technical File requirements: what you need to know

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

How to build a supplier quality management system in 4 simple steps

Why not just use SharePoint as a Document Management System?

How is Software as a Medical device (SaMD) regulated by the FDA?

ISO 9001 vs ISO 13485. What’s the difference?

What is post-market surveillance for medical devices?

8 Tips for Improving the Document Review Process

Is that final? 5 reasons to use document version control software

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

What’s the plan? A seamless product realisation process for ISO 13485

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

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

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

Compiling a design & development plan for your medical device

What is 21 CFR Part 11? FDA requirements explained

The evolution of a Quality Management System

Why design controls matter in Medical Device Development

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

Why not just use Qualio as your medical device eQMS?

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

How to scale your medical device consultancy practice

How a QMS supports medical device risk management in ISO 13485

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

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

Why not use greenlight guru as your med tech eQMS?

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

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

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

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

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

Document Management and Document Control: Is there a difference?

Quality Control VS Quality Assurance. What is the difference?

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

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

Why not just use SharePoint for your Medical Device QMS?

8 powerful benefits of a document management system

What is an Electronic Document Management System (EDMS)?

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

4 ways to build an ISO 13485 compliant medical device QMS

10 reasons fabless semiconductor companies need a document control system

Why not just use Dropbox for your Medical Device QMS?

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

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

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

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

Moving from paper to a digital medical device Quality Management System

QMS documentation requirements in ISO 13485

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

Take it from me: your medical device start-up needs a Lean eQMS

Document control in your medical device Quality Management System

How to stop ‘over-processing’ in your medical device QMS

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

Understanding the regulation: challenges for UK IVD device developers

7 Quality Management Principles of ISO 9001:2015 and how to live by them

What is document control?

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

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

8 GMP principles for med tech developers to live by

In praise of the Design Review Process

Why your company should have a Quality Strategy

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

11 myths about ISO 9001 - busted!

Can Product Innovation Tools help you go 'virtual first?'

A 21 CFR Part 11 checklist: 7 key FDA e-signature requirements

Why your QMS needs to be an eQMS

12 issues with virtual team collaboration tools that you should worry about

Pros and cons of a phase gate process in new product development

Can product innovation happen by accident?

How are lean principles embodied in a good DMS?

7 reasons your business process modelling project is doomed

Managing the change control process for GxP compliance

How secure is your virtual collaboration process?

Preparing for ISO 9001 audits in a virtual world

Process verification vs process validation for medical devices

Supporting product innovation with document control software

Remote collaboration; risk or opportunity for new product development?

6 questions to help you choose a med-tech eQMS

Cognidox v10.1 delivers new features for FDA compliance

Electronic VS Digital Signatures? What do you need for a med-tech eQMS?

Precious Cargo: Covid-19 Vaccines and Good Distribution Practice (GDP)

Organizing Organizational Knowledge: the case for information management in ISO 9001 (Part 2)

9 ways QMS software helps you maintain & demonstrate GxP compliance

How a Document Management System can help build operational resilience

Organizing Organizational Knowledge: the case for information management in ISO 9001 (Part 1)

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

Knowledge or noise? Managing your company’s structured & unstructured data

The 5 Pillars of GMP in the Pharmaceutical Sector

Why document review is critical to successful new product development

GMP v cGMP. What's the difference?

How Lean Documentation Creates Customer Value In The Development Cycle

8 Tips For Documenting SOPs (Standard Operating Procedures)

How to Ruin a New Product Development Process

What Is cGxP?

Are Life Science Companies The New ‘Wildcatters’?

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

9 Ways Innovative Companies Use Their Document Management Software

Another Successful Exit For Another Cognidox Client

8 Reasons To Document Your Standard Operating Procedures (SOP)

Good Distribution Practices (GDP) In the Pharmaceutical Industry

The 5 Stages of Document Control Vital For Effective NPD

UltraSoC - another “Made in Cambridge” success story

Will ISO certification give you a competitive edge?

Where are you on the Quality Management Maturity Grid?

What are the IVDR and MDR requirements for Economic Operators

Cognidox gain ISO 9001:2015 and ISO 27001:2013 certifications

What are the 7 stages of a new product development process?

Digital Signatures: New MHRA guide clarifies remote approval requirements

CBD, GMP and GdocP; quality management in the cannabis industry

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

On the difference between Bug Tracking and Help Desk software

Remote collaboration in the age of Covid-19

Why a file sharing app is not a document management system

From NPD to NPI. Agility and control with a stage gate process

Why corrective action management goes wrong

8 essential success drivers in a new product development process

Organizational knowledge in ISO 9001:2015

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

Looking the wrong way: 7 reasons Document Management Systems fail

Announcing the release of Cognidox v10

Document management for the Life Sciences industry

The trick to a painless new product introduction process

What is effective CAPA management?

The New Year Honours Debacle: A document management disaster

Made in cambridge: our part in a high tech product development success story

What do you really need for successful medical device development?

Organisational knowledge requirements in iso 9001:2015

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

Compliance Vs. Kaizen; how quality management can be part of your DNA

9 ways to screw up your business process mapping

What kind of Product Management Process do you need?

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

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

ISO 27001 and ISO 9001: How an integrated response can work

NASA & the bra makers; quality management in the space race

What does a good change control process look like?

ISO 26262: How can DMS solutions support the development of driverless tech?

5 critical success factors for a new product development process

Can a Stage Gate Process ever be agile?

Choosing the best business management software for your company

Riding the wave of the med-tech quality management challenge

9 ways an Extranet Can Improve your Product Release Process

How to talk to the FDA

New IVD regulation is coming. are you ready?

Google Drive Vs Dropbox as Document Management Systems

EU Medical Device Regulations are changing. How and why?

Seven document control pitfalls and how to avoid them

How to avoid the med tech graveyard with user centred design

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

Quality Management Vs Compliance.  What's the difference?

How a Document Management System can help you fight hyperscale threats

Box Vs Dropbox as Document Management Systems

What investors need to know about your Product Management Process

7 Deadly Sins of the Product Development Process

Why not just use Box as a document management system?

Supply Chain Disruption and the Future of Trust

Prince2 and Document Control

3 Product Development Fails that cost a fortune (and a space craft)

7 tips for designing an effective Business Process Map

5 Reasons to Invest in a Company Management System


The Scale-up Process Gap and the Business Model Canvas

Why the FDA want Proactive Quality Management Systems

The Scale-up Process Gap - Getting Started

How to Build a QMS Your Team Will Actually want to Use

The Process Gap for Scale-up companies

4 sure signs you need to start Business Process Mapping

All You Really Need For Xmas is a Competitive Advantage

Why your Business Management System should be graphical

4 ways to fix a failing product development process with an agile tool-kit

Visualising Risk-Based Thinking in a Quality Management System

Late again? How to conquer the biggest challenge in product development

No more mavericks: Better QA through collaboration

Is your QMS just for ISO certification?

ISO 13485:2016 - decoding the enigma

Burning money in the product development process? Don’t get wasted

5 ways Business Process Modeling can transform your company

How digital signatures can help secure regulatory compliance

Cognidox launches latest upgrade to leading dMS

The product management challenge - when, who and how

Tame the Product Development Cycle with a Lean DMS

How a DMS helps you get the most out of external collaborators

Effective product development with phase-gate control and a DMS

Successful exits with cognidox

Cognidox achieves full iSO 27001 certification

6 ways to improve product release management

Is your information safe? Document security in the information age

Are your ISO inspections painful? How to make your QMS really useful

Improving product development productivity with DMS version control

How to evaluate a document management system

7 questions to ask before choosing your DMS provider