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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
Why not just use Google Drive as a Document 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
Corrective actions: why, when and how?
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
4 steps to build an effective supplier quality management system
Document Control requirements in ISO 9001:2015; what you need to know
How to develop a medical device; the 5 phases of med-tech development
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
Should you use Microsoft software to build your own digital QMS?
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
QSR Compliance: What’s inside FDA 21 CFR Part 820?
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
How's your Quality Management - Ad hoc, analytical or chaordic?
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
ONEDRIVE VS SHAREPOINT AS DOCUMENT MANAGEMENT SYSTEMS
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
Why not just use Dropbox as a document management system?
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
Why not just use SharePoint as a Document Management System?
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
How a document management system contributes to a lean business model
ISO9001 ready with Cognidox – an overview
A closer look at Document Control for ISO 9001
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