DMS Insights from Cognidox

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

Why not just use Dropbox as a document management system?

QSR COMPLIANCE_FDA 21 CFR Part 820

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

What are the 5 phases of medical device development?

Fire in front of a group of fire extinguishers

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

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

A picture of a white sea bird in a gaggle of grey sea birds

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

Medical Device Technical File requirements: what you need to know

Quality-management-vs-compliance

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

supplier quality management system

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

EM459-Sharepoint-blog-header-image

Why not just use SharePoint as a Document Management System?

Person using software as medical device

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

An image of a question mark made from a stethescope

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

A pair of binoculars breaking through a wall

What is post-market surveillance for medical devices?

8 Tips for Improving the Document Review Process

Document Management Software

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

What is a medical device?

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

Product Realisation ISO 13485

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

Medical device audits

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

FDA CAPA

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

QMS, eQMS or eDMS

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

Compiling a design & development plan for your medical device

Compiling a design & development plan for your medical device

What is FDA 21 CFR Part 11?

What is 21 CFR Part 11? FDA requirements explained

Quality Management System Evolution

The evolution of a Quality Management System

Why design controls matter in Medical Device Development

FDA 510K vs PMA

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

Why not just use Qualio as your medical device eQMS?

Gxp compliance

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

How to scale your medical device consultancy practice

Medical device risk management

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

greenlight guru review

Why not use greenlight guru as your med tech eQMS?

Image of documents flying through the air

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

Image of a big bowl chips to illustrate an article on RISC-V chips

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 DHF medical device requirements

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

Difference between document management and document control

Document Management and Document Control: Is there a difference?

Quality Control Vs Quality Assurance

Quality Control VS Quality Assurance. What is the difference?

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

FDA inspector confirming design controls are in place

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

Sharepoint medical device QMS

Why not just use SharePoint for your Medical Device QMS?

Picture of classic tools

8 powerful benefits of a document management system

What is an Electronic 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 Quality Management System

4 ways to build an ISO 13485 compliant medical device QMS

semiconductor companies document control

10 reasons fabless semiconductor companies need a document control system

Should you use dropbox as medical device qms?

Why not just use Dropbox for your Medical Device QMS?

document contol software for medical device developers

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

document management software

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

Money wasted through document anarchy

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

google drive for medical device quality management system

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

moving from paper to medical device eqms

Moving from paper to a digital medical device Quality Management System

QMS documentation structure for ISO 13485

QMS documentation requirements in ISO 13485

flying business documents

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

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

Women in a laboratory undertaking document control

Document control in your medical device Quality Management System

A teetering stack of medical QMS files

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

What is the UK Responsible person?

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

Understanding the regulation: challenges for UK IVD device developers

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

What is document control? A question mark on a keyboard

What is document control?

Man throwing mask away - post-covid impact on IVDR

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

A clock showing time is running out for IVDR compliance

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

8 GMP principles

8 GMP principles for med tech developers to live by

In praise of the Design Review Process

In praise of the Design Review Process

Quality Strategy

Why your company should have a Quality Strategy

Document control software

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

11 myths about ISO 9001 - busted!

11 myths about ISO 9001 - busted!

Digital product innovation

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

e-Signature

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

QMS or eQMS?

Why your QMS needs to be an eQMS

Collaboration Tools

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

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

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

Product Innovation by accident

Can product innovation happen by accident?

5 principles of Lean Document Management

How are lean principles embodied in a good DMS?

Business Process Modelling project is doomed

7 reasons your business process modelling project is doomed

Change control process GxP compliance

Managing the change control process for GxP compliance

virtual collaboration-secure collaboration tools

How secure is your virtual collaboration process?

Preparing for ISO 9001 audits in a virtual world

Preparing for ISO 9001 audits in a virtual world

process validation for medical devices

Process verification vs process validation for medical devices

Product Innovation takes a lot of thought

Supporting product innovation with document control software

Remote Collaboration New Product Development

Remote collaboration; risk or opportunity for new product development?

6 questions to help you choose a med-tech eQMS

6 questions to help you choose a med-tech eQMS

New release

Cognidox v10.1 delivers new features for FDA compliance

Digital Signature

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

Coronavirus Good Distribution Practice (GDP)

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

information-management-iso-9001-660x330

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

9 ways an eQMS can support GXP compliance

9 ways QMS software helps you maintain & demonstrate GxP compliance

Operational resilience_document management

How a Document Management System can help build operational resilience

information-management-iso-9001-p1-660x330

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

Med tech investment-bionic pig

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

Structured and unstructured data

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

5Ps of GMP

The 5 Pillars of GMP in the Pharmaceutical Sector

Document review_New Product Development

Why document review is critical to successful new product development

GMP v cGMP. What's the difference?

GMP v cGMP. What's the difference?

How Lean Documentation Creates Customer Value In The Development Cycle

How Lean Documentation Creates Customer Value In The Development Cycle

7 Tips For Documenting SOPs (Standard Operating Procedures)

8 Tips For Documenting SOPs (Standard Operating Procedures)

How to ruin your New Product Development Process

How to Ruin a New Product Development Process

cGxP

What Is cGxP?

life science companies

Are Life Science Companies The New ‘Wildcatters’?

Medical Device Development Glossary-2

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

Innovate with Document Management Software

9 Ways Innovative Companies Use Their Document Management Software

Document Management

Another Successful Exit For Another Cognidox Client

Standar Operating Procedures

8 Reasons To Document Your Standard Operating Procedures (SOP)

FDA-GDP-Good Distribution Practices

Good Distribution Practices (GDP) In the Pharmaceutical Industry

Document Control in New Product Development

The 5 Stages of Document Control Vital For Effective NPD

Ultrasoc_Siemens

UltraSoC - another “Made in Cambridge” success story

ISO Certification Competitive Edge

Will ISO certification give you a competitive edge?

Quality Management Maturity Grid

Where are you on the Quality Management Maturity Grid?

What is a med tech economic operator?

What are the IVDR and MDR requirements for Economic Operators

Certifications

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

7 phases of New Product Development Process

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

Digital Signature MHRA Remote Working

Digital Signatures: New MHRA guide clarifies remote approval requirements

Good Documentation Practice for CBD industry

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

How to compile a Design History File (DHF)

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

bug-finding

On the difference between Bug Tracking and Help Desk software

Remote Collaboration Covid-19

Remote collaboration in the age of Covid-19

Why a file sharing app is not a document management system

Why a file sharing app is not a document management system

Stage gate processes

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

when CAPA goes wrong

Why corrective action management goes wrong

Success drivers in a NPI

8 essential success drivers in a new product development process

organisational-knowledge-660x330

Organizational knowledge in ISO 9001:2015

ISO 14971

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

7 reasons Document Management Systems fail

Looking the wrong way: 7 reasons Document Management Systems fail

Announcing the release of Cognidox v10

Announcing the release of Cognidox v10

document management for the life sciences industry

Document management for the Life Sciences industry

New product introduction process

The trick to a painless new product introduction process

CAPA management

What is effective CAPA management?

Data Security

The New Year Honours Debacle: A document management disaster

Silcon Fen story

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

cognidox-blog-featured

What do you really need for successful medical device development?

oragnisational knowledge ISO 9001:2015

Organisational knowledge requirements in iso 9001:2015

chicken and egg med tech concept

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

Kaizen

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

business process map

9 ways to screw up your business process mapping

Product Management Process

What kind of Product Management Process do you need?

MDSW_IVD_MDR

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

cognidox-gamp-5

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

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

Quality Management

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

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What does a good change control process look like?

DMS solutions support the development of driverless tech

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

5 critical success factors product development

5 critical success factors for a new product development process

stage gate process2

Can a Stage Gate Process ever be agile?

Business management software

Choosing the best business management software for your company

Med Tech Quality Management

Riding the wave of the med-tech quality management challenge

Extranet Product Release

9 ways an Extranet Can Improve your Product Release Process

How to talk to the FDA

How to talk to the FDA

IVD Device

New IVD regulation is coming. are you ready?

google-vs-dropbox

Google Drive Vs Dropbox as Document Management Systems

EU Medical Device Regulations are changing

EU Medical Device Regulations are changing. How and why?

Doument Control Pitfalls

Seven document control pitfalls and how to avoid them

User centred design

How to avoid the med tech graveyard with user centred design

Google-team-drives_Document Management System

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

Quality Management vs Complaince

Quality Management Vs Compliance. What's the difference?

Hyperscale threats Document Management System

How a Document Management System can help you fight hyperscale threats

box-vs-dropbox-1

Box Vs Dropbox as Document Management Systems

VCs and Project Management

What investors need to know about your Product Management Process

rendered-2

7 Deadly Sins of the Product Development Process

Is Box a Document Management System?

Why not just use Box as a document management system?

Supply Chain Management

Supply Chain Disruption and the Future of Trust

Prince2 and Document Control

Mars Orbiter Product Development Fail

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

Designing a Business Process Map

7 tips for designing an effective Business Process Map

Company Management System

5 Reasons to Invest in a Company Management System

Onedrive-vs-sharepoint

ONEDRIVE VS SHAREPOINT AS DOCUMENT MANAGEMENT SYSTEMS

business-model-canvas-66x330

The Scale-up Process Gap and the Business Model Canvas

FDA prioritising Proactive Quality Management System

Why the FDA want Proactive Quality Management Systems

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The Scale-up Process Gap - Getting Started

A QMS YOU WILL WANT TO USE

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

process-gap-for-scale-ups

The Process Gap for Scale-up companies

4 signs you need to start mapping your business processes

4 sure signs you need to start Business Process Mapping

All You Really Need For Xmas is a Competitive Advantage

All You Really Need For Xmas is a Competitive Advantage

why your business management system should be graphical

Why your Business Management System should be graphical

HOW TO FIX A FAILING PRODUCT DEVELOPMENT PROCESS

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

Risk based thinking in a quality management system

Visualising Risk-Based Thinking in a Quality Management System

the greatest challenge in product development

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

No More Mavericks; Better QA through collaboration

No more mavericks: Better QA through collaboration

Just for your ISO Certification-1

Is your QMS just for ISO certification?

Understanding ISO 13485_2016

ISO 13485:2016 - decoding the enigma

Product Development Process

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

business-process-modelling

5 ways Business Process Modeling can transform your company

Digital Signatures

How digital signatures can help secure regulatory compliance

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Cognidox launches latest upgrade to leading dMS

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The product management challenge - when, who and how

Control the Product Development Cycle

Tame the Product Development Cycle with a Lean DMS

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

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Effective product development with phase-gate control and a DMS

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Successful exits with cognidox

Cognidox achieves full iSO 27001 certification

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6 ways to improve product release management

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Is your information safe? Document security in the information age

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

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Improving product development productivity with DMS version control

evaluate document management system

How to evaluate a document management system

Questions to ask before choosing DMS provider

7 questions to ask before choosing your DMS provider