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Having a repeatable procedure for Corrective and Preventive Action (CAPA) is a key FDA requirement for medical...
Having a repeatable procedure for Corrective and Preventive Action (CAPA) is a key FDA requirement for medical...
WTH is FDA 21 CFR Part 11? That’s a question many life science developers wanting to access the US market must...
Managing the integrity and accessibility of a PSMF (Pharmacovigilance System Master File) is a key challenge f...
At last! It’s happened! The FDA has announced the date for the publication of its new Quality Management Syste...
The regulations and literature surrounding medical device development are packed with acronyms and technical t...
The FDA’s Quality System Regulation (QSR) for medical device manufacturers is commonly known as FDA 21 CFR Par...
SMEs creating a digital Quality Management System (QMS) will often reach for the most familiar tools to build ...
Does the fertility tracking app you are developing count as a medical device? What about the imaging software ...
So, you’ve had your brilliant idea. You know what kind of medical device you want to build. You have a vision ...
How can medical device developers gain FDA approval for their devices and permission to sell their product int...
Developers who want to release a medical device in the US need to seek permission from the FDA. Depending on t...
DHF, DMR, DHR… to the uninitiated they might sound like out-of-town furniture stores or airport codes for exot...
30 years ago the FDA introduced robust new requirements for medical device design control following a string o...
How does your organisation authorise, authenticate, document and police the use of electronic signatures withi...
When Elon Musk unveiled his ‘bionic pig’ in an on-line event in September there was much hype and more than a ...
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....
I am a former FDA staff member and now back in the private sector. If you are in Regulatory Affairs, you are i...
Reports from the U.S. tell us the FDA is continuing to prioritise Proactive Quality Management in the medical ...
Digital signatures are proving valuable tools for businesses developing products for release in highly regulat...
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