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A QMS should ultimately help guard against customer harm or dissatisfaction, by guarding against the risk of f...
A QMS should ultimately help guard against customer harm or dissatisfaction, by guarding against the risk of f...
To launch a medical device in the US, developers must gain FDA permission. For most Class II devices, this inv...
The semiconductor shortage continues to ravage many sectors. With its reliance on electronics for driverless t...
The rise of RISC-V seems inexorable. It’s being touted as an answer to the drastic slowing of Moore’s law. It’...
Cambridge, UK, 3 May 2022: Cognidox, a leading provider of document management solutions for the high-tech, me...
DHF, DMR, DHR… to the uninitiated they might sound like out-of-town furniture stores or airport codes for exot...
QC is about detecting defects in your finished product, while QA is about preventing the defects from occurrin...
The Device Master Record (DMR) is one of the ‘holy trinity’ of files that developers need to collate and maint...
30 years ago the FDA introduced robust new requirements for medical device design control following a string o...
A document management system (DMS) is a method of managing, storing and retrieving all the documentation a bus...
In medical device development, document controls are the building blocks of an ISO and FDA compliant Quality M...
DropBox is a well-known cloud storage and file-sharing platform. Its sleek interface and seamless collaboratio...
Inflexible SOPs, complicated interfaces, training and maintenance requirements. Traditional document control s...
Managing your document lifecycle is central to achieving ISO 9001 compliance. This guide explains how to struc...
Chaotic document management is wasting the time and energy of businesses around the world every year. But in s...
In this blog, Shaun Knights, Head of Quality at period care company Callaly, tells us why his start-up needed ...
Document controls are a fundamental requirement of every medical device regulatory regime. They are the ‘build...
Building an effective Quality Management System (QMS) for medical device development is rarely quick or simple...
Following Britain’s exit from the EU, all non-UK medical device and IVD manufacturers who want to place their ...
IVD device regulation is about upping the bar—it’s about making products to a higher standard and ensuring the...
ISO 9001:2015 and its related quality standards are all based on the ‘Seven Quality Management Principles’ def...
The Covid pandemic has brought new attention, investment and competition to the IVD sector. But with new oppor...
The EU In Vitro Diagnostics Regulation (IVDR), written in 2017, was developed to replace the existing EU In Vi...
Good Manufacturing Practices (GMP) are intended to ensure that pharmaceutical products, medical devices and ot...
I believe that a quality strategy is a vital element to the success of a business. Quality of product and oper...
Mention ISO 9001 to most people, or tell them that you implement quality systems, and they'll start glazing ov...
Colocation was one of the central tenets of the Agile manifesto, but times have changed. With all the new digi...
Are your e-signatures compliant with FDA 21 CFR Part 11? For medical device developers, ensuring your electron...
If you want to develop a Quality Management System that meets the regulation and powers your commercial succes...
Struggling with remote teamwork despite having all the apps? You're not alone. In this article, we explore 12 ...
Can product innovation really happen by accident? Penicillin, Viagra and the humble Post-It note were all famo...
Does your Document Management System (DMS) apply the five Lean principles to the way you work?
Last year, Slack, Zoom and countless other companies hoovered up business as companies shifted to support new ...
Companies often embark on business process modelling projects with the best of intentions. Modelling may be a ...
For those who need ISO 9001:2015 certification, virtual audits are currently taking the place of face to face ...
Process verification and validation should be a key part of a medical device manufacturer’s QMS. But what’s th...
In the history of product innovation, stories of happy accidents abound. The list of inventions stumbled upon ...
Remote collaboration is the new normal and set to be a major feature of the post-Covid world. Workers have fou...
Choosing and installing a med tech eQMS is a resource and time-hungry undertaking. And the stakes are high. If...
Cambridge, UK, 18th Jan 2021: Cognidox, a leading provider of document management solutions for the medical de...
The race for the development of a Covid-19 vaccine has been an incredible story of fast tracked innovation. Th...
In Part 1 of this series we considered the problem of reinvention, the unstructured nature of information, and...
Throughout the med-tech regulatory literature quality systems are cited as the way GxP (current best practice)...
If you’re not planning to improve your operational resilience, you’ve not been paying attention. How can a dig...
In a previous blog, we wrote that information findability is as worthy a topic for ISO 9001:2015 standards-mak...
When Elon Musk unveiled his ‘bionic pig’ in an on-line event in September there was much hype and more than a ...
Unstructured data present both a compliance risk and a missed opportunity for growing organisational knowledge...
GMP is part of the best practice guidelines (GxP) which the FDA and other official bodies refer to in their re...
In a Lean approach to product development, customer value is defined as ‘everything the customer is prepared t...
It’s much easier to screw up a new product development process than mastermind a successful one. Here’s how.
cGxP (also known simply as GxP) is an acronym used by the FDA and other regulators within the life science ind...
Research shows one of the key challenges for life science companies is balancing the need for rapid innovation...
The outlook for many companies might be unpredictable at the moment, but access to the right document manageme...
The US human interface company, Snyaptics Inc announced this week that they are acquiring DisplayLink Corp in ...
Managing the quality of medical products as they are stored and distributed brings with it many challenges. Di...
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