The latest news and updates from cognidox

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...

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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...

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4 steps to build an effective supplier quality management system

Supplier management needs to be a collaborative and proactive process if it’s going to deepen key relationship...

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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 develop a medical device; the 5 phases of med-tech development

The medical device development process is typically broken down into five distinct phases.  Each one requires ...

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What is document control?

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

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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...

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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...

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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...

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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...

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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...

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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 ...

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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...

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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...

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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...

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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...

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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...

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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...

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Can product innovation happen by accident?

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

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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?

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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 ...

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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...

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How secure is your virtual collaboration process?

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

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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 ...

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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...

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Supporting product innovation with document control software

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

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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...

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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...

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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...

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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...

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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...

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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...

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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)...

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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...

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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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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...

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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 ...

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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...

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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...

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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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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...

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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...

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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...

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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...

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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.

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What Is cGxP?

cGxP (also known simply as GxP) is an acronym used by the FDA and other regulators within the life science ind...

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Are Life Science Companies The New ‘Wildcatters’?

Research shows one of the key challenges for life science companies is balancing the need for rapid innovation...

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

The regulations and literature surrounding medical device development are packed with acronyms and technical t...

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9 Ways Innovative Companies Use Their Document Management Software

The outlook for many companies might be unpredictable at the moment, but access to the right document manageme...

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Another Successful Exit For Another Cognidox Client

The US human interface company, Snyaptics Inc announced this week that they are acquiring DisplayLink Corp in ...

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8 Reasons To Document Your Standard Operating Procedures (SOP)

Documenting your SOP (standard operating procedures) can be a drag. It can feel unnecessary for a relatively s...

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