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On 30 October 2025, the UK Government signed new clinical trials legislation into law, marking a significant m...
On 30 October 2025, the UK Government signed new clinical trials legislation into law, marking a significant m...
What are the seven stages of the document lifecycle, and why is lifecycle essential to an effective Quality Ma...
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In pharmaceutical and life science manufacturing, quality relies on the co-ordinated control of five critical ...
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Medical device audits can be a source of stress for developers and manufacturers. But what exactly are the aud...
Many CTUs are turning to SharePoint to shift from paper to electronic Trial Master Files - after all, it's acc...
Whether you're developing a brand new medical device or scaling your team to expand existing operations, there...
As clinical trials become increasingly complex and resources tighten, UK Clinical Trial Units are moving away ...
Cambridge, UK – October 2025 - Recur Software, a US-based software group that acquires and grows industry-spec...
WTH is FDA 21 CFR Part 11? That’s a question many life science developers wanting to access the US market must...
Whether you're running trials as a CRO, scaling production as a CMO, or delivering end-to-end solutions as a C...
The med tech sector is booming, but many companies are silently leaking time, money and talent through an over...
It’s the job of your corrective action process to identify and eliminate the systemic issues that will prevent...
Google Drive is a hugely popular, cloud-based program that allows you to create, edit, store, and share docume...
In the earliest stages of building a medical device business, training compliance is often handled with a DIY ...
In practice, the terms Learning Management System (LMS) and Training Management System (TMS) are often used in...
The PIP scandal, in which faulty breast implants injured thousands of women around the world, served as a powe...
A Quality Management System (QMS) is a requirement for medical device developers across the globe. But should ...
While not a formal regulatory term, Good Training Practice (GTrP) is emerging as a shorthand in quality-focuse...
How do you log and deal with non-conformities so that faulty products don't end up in the hands of customers? ...
Every time a deviation is blamed on “human error,” an opportunity for real improvement is lost. In high-stakes...
Navigating the complexities of ISO 13485:2016 can be daunting - especially for innovative start-ups and scale ...
When you’re under pressure to gain ISO 13485 or accelerate FDA QMSR compliance, the idea of prompting ChatGPT ...
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You asked for it, and we built it! The Cognidox Learning Management System (LMS) is now ready to become an int...
Are you looking for ways to build and maintain the most efficient, ISO 13485 QMS as your company continues to ...
What is the best document management solution for you and your business, One Drive for Business or SharePoint?...
As a growing Contract Research Organisation (CRO), you understand the critical role of the Trial Master File (...
Bringing a medical device to market is one of the most rewarding and high-stakes journeys a startup can undert...
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What is the medical device technical file? What should it contain and how should it be structured? And is it e...
I worked in one of the large Cambridge-based technology consultancies for many years and was privileged to hav...
For medical device startups, implementing a Quality Management System (QMS) isn’t a one-time event - it’s an o...
Greenlight Guru has been marketed since 2013 as the first digital eQMS (electronic Quality Management System) ...
A med tech learning management system (LMS) is not just a repository for training videos and quizzes. And it n...
In clinical trial management two sets of documents are essential to success: the Trial Master File (TMF) and t...
It’s a fair question - especially when you’re staring down the barrel of an audit, short on time, and knee-dee...
A Quality Management System is a requirement for medical device developers across the globe. But should you bu...
Managing clinical trial documents manually can be a major headache. From consent forms to sample tracking logs...
If your company needs to certify your Quality Management System (QMS) to the ISO 13485 standard, knowing how t...
When you bring a medical device to market, you’re stepping into one of the most competitive and regulated indu...
SMEs creating a digital Quality Management System (QMS) often turn to familiar, digital tools to build a solut...
How should you structure your documentation to meet the requirements of ISO 13485?
Training management is a big deal for medical device developers. Get it wrong, and you risk fines, product rec...
The regulations and literature surrounding medical device development are packed with acronyms and technical t...
There are different ways companies can build required quality management systems, from using traditional paper...
The medical device development process is typically broken down into five distinct phases. Each one requires i...
Documentation continues to be of vital importance to medical device development in the age of AI. One example?...
Box is a popular cloud-based content management solution that companies use to manage files and collaborate on...
From February 2, 2026, all medical device manufacturers and importers selling their products in the USA will n...
Inadequate document review is often the root cause of failure in new product development and manufacturing pro...
The integration of Artificial Intelligence (AI) into medical devices represents one of the most promising yet ...
There are many eQMS platforms out there that have been helping medical device developers bring their products ...
In the past, document management was an unglamorous business. Not every company was digitised, and those that ...
Short answer? Yes. But not in the way you'd expect—and that’s been the secret to its success. Here’s the truth...
For some companies simply managing their documentation is enough to support their business goals. But others n...
MasterControl is one of the most widely known electronic Quality Management Systems (eQMS) in the life science...
Cambridge, UK, 22 October 2024: Cognidox, a leading provider of document management solutions for high-tech, m...
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