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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...
What is the medical device technical file? What should it contain and how should it be structured? And is it e...
The FDA’s new QMSR is dropping the reference to the DHF (Design History File) when it takes effect in 2026. Bu...
Medical device audits can be a source of stress for developers and manufacturers. But what exactly are the aud...
ISO 14971:2019 defines the international requirements of risk management systems for medical devices. How does...
Post-Brexit, there is still confusion about the future use of the UKCA (UK Conformity Assessed) markings and w...
The case for ditching paper based QMS (Quality Management Systems) can seem like a no-brainer. But faced with ...
Controlling and documenting IQ, OQ and PQ effectively is a complex and time-consuming process for life science...
Clinical research demands strict GCP (Good Clinical Practice) compliance. But many institutions stuck with out...
Transferring design to production is a process that can be fraught with risk for medical device developers. Ho...
There’s plenty of document management and file-sharing software available on the market, but not all of it is ...
The regulations and literature surrounding medical device development are packed with acronyms and technical t...
The medical device development process is typically broken down into five distinct phases. Each one requires i...
The PIP scandal, in which thousands of women were injured by faulty breast implants over a period of twenty ye...
Question for you: what exactly is a medical device? Is the product you are developing a Medical Device, an In ...
What are the planning requirements for a medical device design and development process? And what tools can hel...
When it comes to medical device development, the absence of comprehensive design and development documentation...
A QMS should ultimately help guard against customer harm or dissatisfaction, by guarding against the risk of f...
Greenlight Guru has been marketed since 2013 as the first digital eQMS (electronic Quality Management System) ...
DHF, DMR, DHR… to the uninitiated they might sound like out-of-town furniture stores or airport codes for exot...
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...
In medical device development, document controls are the building blocks of an ISO and FDA compliant Quality M...
DropBox is a file sharing platform familiar to millions throughout the world. Once a personal file storage and...
Inflexible SOPs, complicated interfaces, training and maintenance requirements. Traditional document control s...
Chaotic document management is wasting the time and energy of businesses around the world every year. But in s...
A Quality Management System is a requirement for medical device developers across the globe. But should you bu...
Building a quality management system is never a quick and simple process. But in medical device development, w...
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...
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...
Process verification and validation should be a key part of a medical device manufacturer’s QMS. But what’s th...
When Elon Musk unveiled his ‘bionic pig’ in an on-line event in September there was much hype and more than a ...
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...
Managing the quality of medical products as they are stored and distributed brings with it many challenges. Di...
There are four entities defined under the EU MDR and IVDR as “economic operators”. Under the regulation, these...
A lot of us have been challenged by remote working lately, whether it’s the back ache acquired from working on...
The third edition of ISO 14971 (Application of Risk Management to Medical Devices) was released in December 20...
There’s no shortage of words in print and online written by regulators, consultants and software developers ab...
What should come first in a med tech project? Product development or documentation?
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...
From 2022 the In Vitro Diagnostics Regulation (IVDR) will require Notified Body intervention and review for 80...
A med tech device that has a poor user experience can be dangerous for consumers and commercially calamitous f...
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