The latest news and updates from cognidox

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

Inflexible SOPs, complicated interfaces, training and maintenance requirements. Traditional document control s...

Read More

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...

Read More

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...

Read More

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...

Read More

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 ...

Read More

QMS documentation requirements in ISO 13485

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

Read More

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...

Read More

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 ...

Read More

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...

Read More

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...

Read More

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 ...

Read More

Understanding the regulation: challenges for UK IVD device developers

IVD device regulation is about upping the bar—it’s about making products to a higher standard and ensuring the...

Read More

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

ISO 9001:2015 and its related quality standards are all based on the ‘Seven Quality Management Principles’ def...

Read More

What is document control?

How much control do you have over the documents your business generates? How much do you need?

Read More

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

The Covid pandemic has brought new attention, investment and competition to the IVD sector. But with new oppor...

Read More

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

The EU In Vitro Diagnostics Regulation (IVDR), written in 2017, was developed to replace the existing EU In Vi...

Read More

8 GMP principles for med tech developers to live by

Good Manufacturing Practices (GMP) are intended to ensure that pharmaceutical products, medical devices and ot...

Read More

In praise of the Design Review Process

I worked in one of the large Cambridge-based technology consultancies for many years and was privileged to hav...

Read More

Why your company should have a Quality Strategy

I believe that a quality strategy is a vital element to the success of a business. Quality of product and oper...

Read More

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

There’s plenty of document management and file-sharing software available on the market, but not all of it is ...

Read More

11 myths about ISO 9001 - busted!

Mention ISO 9001 to most people, or tell them that you implement quality systems, and they'll start glazing ov...

Read More

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

Colocation was one of the central tenets of the Agile manifesto, but times have changed. With all the new digi...

Read More

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

How does your organisation authorise, authenticate, document and police the use of electronic signatures withi...

Read More

Why your QMS needs to be an eQMS

If you want to develop a Quality Management System that meets the regulation and powers your commercial succes...

Read More

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

As your computer waits to load up Teams, Zoom, Slack, Accello and countless other collaboration apps every mor...

Read More

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

Will a phase gate process hold back or enhance your new product development? What are the pros and cons of sta...

Read More

Can product innovation happen by accident?

Can product innovation really happen by accident? Penicillin, Viagra and the humble Post-It note were all famo...

Read More

How are lean principles embodied in a good DMS?

Does your Document Management System (DMS) apply the five Lean principles to the way you work?

Read More

7 reasons your business process modelling project is doomed

Companies often embark on business process modelling projects with the best of intentions. Modelling may be a ...

Read More

Managing the change control process for GxP compliance

Change control in life science development is critical to ensuring the ultimate safety of end users. And havin...

Read More

How secure is your virtual collaboration process?

Last year, Slack, Zoom and countless other companies hoovered up business as companies shifted to support new ...

Read More

Preparing for ISO 9001 audits in a virtual world

For those who need ISO 9001:2015 certification, virtual audits are currently taking the place of face to face ...

Read More

Process verification vs process validation for medical devices

Process verification and validation should be a key part of a medical device manufacturer’s QMS. But what’s th...

Read More

Supporting product innovation with document control software

In the history of product innovation, stories of happy accidents abound. The list of inventions stumbled upon ...

Read More

Remote collaboration; risk or opportunity for new product development?

Remote collaboration is the new normal and set to be a major feature of the post-Covid world.  Workers have fo...

Read More

6 questions to help you choose a med-tech eQMS

Choosing and installing a med tech eQMS is a resource and time-hungry undertaking. And the stakes are high. If...

Read More

Cognidox v10.1 delivers new features for FDA compliance

Cambridge, UK, 18th Jan 2021: Cognidox, a leading provider of document management solutions for the medical de...

Read More

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

Would your business benefit from using electronic signatures within your digital quality management system (eQ...

Read More

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

The race for the development of a Covid-19 vaccine has been an incredible story of fast tracked innovation. Th...

Read More

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

In Part 1 of this series we considered the problem of reinvention, the unstructured nature of information, and...

Read More

9 ways QMS software helps you maintain & demonstrate GxP compliance

Throughout the med-tech regulatory literature quality systems are cited as the way GxP (current best practice)...

Read More

How a Document Management System can help build operational resilience

If you’re not planning to improve your operational resilience, you’ve not been paying attention. How can a dig...

Read More

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

  In a previous blog, we wrote that information findability is as worthy a topic for ISO 9001:2015 standards-m...

Read More

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

When Elon Musk unveiled his ‘bionic pig’ in an on-line event in September there was much hype and more than a ...

Read More

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

Unstructured data present both a compliance risk and a missed opportunity for growing organisational knowledge...

Read More

The 5 Pillars of GMP in the Pharmaceutical Sector

For pharmaceutical and other life science disciplines, the ‘5Ps of GMP’ are a useful way of thinking about the...

Read More

Why document review is critical to successful new product development

Inadequate document review is often to blame for failure in new product development and manufacturing processe...

Read More

GMP v cGMP. What's the difference?

GMP is part of the best practice guidelines (GxP) which the FDA and other official bodies refer to in their re...

Read More

How Lean Documentation Creates Customer Value In The Development Cycle

In a Lean approach to product development, customer value is defined as ‘everything the customer is prepared t...

Read More

8 Tips For Documenting SOPs (Standard Operating Procedures)

There are many reasons why an organisation might need to document their SOPs. From training staff and identify...

Read More

How to Ruin a New Product Development Process

It’s much easier to screw up a new product development process than mastermind a successful one.  Here’s how.

Read More