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Managing the quality of medical products as they are stored and distributed brings with it many challenges. Di...
Managing the quality of medical products as they are stored and distributed brings with it many challenges. Di...
There are five stages of document control critical to NPD and product management. If you have the digital tool...
Last week, news broke that Siemens is acquiring the Cambridge based company and Cognidox client, UltraSoC, in ...
The expense and effort of achieving ISO certification is sometimes regarded as excessive and onerous by SMEs -...
Under the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), four distinct roles ar...
Cambridge, UK, 22 May 2020: Cognidox, a leading provider of document management solutions for the high-tech, m...
A brief internet search will confidently tell you that there are anywhere between 4 and 8 stages of the ‘ideal...
A lot of us have been challenged by remote working lately, whether it’s the back ache acquired from working on...
Around the world different rules apply for the cultivation, manufacture and sale of cannabis and CBD products....
There's a long-running debate whether a bug or defect tracking software tool is just a synonym for a help or s...
There are many file sharing apps on the market right now. They range from ‘free’ or ‘low cost’ one size fits a...
Developing a robust stage gate process is a vital part of many new product development (NPD) and introduction ...
ISO 13485, the FDA and the MHRA all require medical device manufacturers to have documented corrective action ...
For most high tech companies, developing profitable new products is their entire reason for being.
One of the areas included in the ISO 9001 :2015 is 7.1.6 Organizational knowledge. The stated requirement is: ...
The third edition of ISO 14971 (Application of Risk Management to Medical Devices) was released in December 20...
Many organisations still operate without a central, shared Document Management System (DMS) that effectively m...
Cognidox’s commitment to improving usability and cross platform accessibility continues with the release of v1...
If you took a snapshot of document management around 20 years ago, the general situation was that in my indust...
Managing an NPI process can be fraught with difficulty as each new initiative brings with it the potential for...
Mastering CAPA management is part of the proactive quality mindset that regulators demand, but it is also an a...
We’ve all been there, haven’t we? We’ve all accidentally published online the addresses of hundreds of celebri...
Cognidox’s story is bound up with that of the "Cambridge Phenomenon" the so-called Silicon Fen high-tech clust...
There’s no shortage of words in print and online written by regulators, consultants and software developers ab...
The pursuit of quality in any company depends on your ability to transmit all kinds of organisational knowledg...
What should come first in a med tech project? Product development or documentation?
Companies working in heavily regulated sectors might have been historically slow to change and optimise their ...
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Companies are often spurred to undertake business process mapping to improve their quality management.
How do you need your product management process to function? A classic article in the HBR got us thinking abou...
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As the 2020 deadline for compliance with the EU’s new Medical Device Regulation (MDR) fast approaches, the EC’...
The Good Automated Manufacturing Practice (GAMP 5 ®) guidelines define a set of core principles for GxP, as pr...
Many high tech businesses who are implementing a Quality Management System (QMS) to gain ISO 9001:2015, are in...
In 1969 quality management was truly the final frontier in the space race. As NASA engineers developed unique ...
A change control process is a vital part of any product development and management function. But if it’s not e...
Advanced Driver Assistance Systems (ADAS) and even driverless cars, once the stuff of science fiction, are rap...
A responsive new product development (NPD) process has always been a key part of a high tech business strategy...
Can you ever make a stage-gate process Agile? Can modern tools and a hybrid approach to Waterfall and Agile br...
Not all business management software (BMS) solutions are created equal. Some are designed for enterprise-wide ...
Time and costs can soon rack up in a med tech device design and development cycle. But those who have installe...
Issuing a tech product release or a software update can be a challenging process. Handled badly it can result ...
I am a former FDA staff member and now back in the private sector. If you are in Regulatory Affairs, you are i...
From 2022 the In Vitro Diagnostics Regulation (IVDR) will require Notified Body intervention and review for 80...
Google Drive and Dropbox are two of the most popular cloud-based, file-sharing platforms on the market today. ...
From 2020 and 2022, EU Medical Device Regulations will change. This brings certain products into regulatory sc...
Do your systems give you the kind of control over your documentation which really match the organisational, co...
A med tech device that has a poor user experience can be dangerous for consumers and commercially calamitous f...
Google Team Drive is a service which has been available by default to Business, Enterprise and Education G-Sui...
For many companies, compliance is, at best, regarded as a necessary evil, and at worst a never-ending ordeal. ...
There is always commercial pressure on product developers to find better and more efficient ways to collaborat...
While Dropbox and Box are widely used cloud file sharing tools, many regulated businesses — especially those s...
Founders of companies are often, by necessity, their own Product Managers. They’re often the ones who have mos...
OK, we admit it, there are definitely more than 7 deadly sins of the product development process. In fact, the...
With a supply chain ripe for digital disruption, high tech manufacturing companies must evolve new ways of man...
Document control is a crucial part of any project management process. In this blog post we ask how the right D...
We all make mistakes, but when a product development process fails it can have far-reaching financial and comp...
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