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QMSR vs ISO 13485

FDA Compliance

QMSR and ISO 13485:2016: what’s in the new FDA regulation?

At last! It’s happened! The FDA has announced the date for the publication of its new Quality Management Syste...

5 min read

Medical Device Development Glossary-2

Medical Device Development FDA Compliance

An A-Z of Medical Device Development; Acronyms, Regulatory & Technical Terms

The regulations and literature surrounding medical device development are packed with acronyms and technical t...

9 min read

QSR COMPLIANCE_FDA 21 CFR Part 820

GxP FDA Compliance

QSR Compliance: What’s inside FDA 21 CFR Part 820?

The FDA’s Quality System Regulation (QSR) for medical device manufacturers is commonly known as FDA 21 CFR Par...

5 min read

ISO 9001:2015 Quality Management System FDA Compliance Document Management and Control

Should you use Microsoft software to build your own digital QMS?

SMEs creating a digital Quality Management System (QMS) will often reach for the most familiar tools to build ...

5 min read

Person using software as medical device

FDA Compliance

How is Software as a Medical device (SaMD) regulated by the FDA?

Does the fertility tracking app you are developing count as a medical device? What about the imaging software ...

5 min read

Product Realisation ISO 13485

FDA Compliance

What’s the plan? A seamless product realisation process for ISO 13485

So, you’ve had your brilliant idea. You know what kind of medical device you want to build. You have a vision ...

4 min read

FDA CAPA

FDA Compliance

What are the FDA's requirements for CAPA (Corrective And Preventive Action)

Having a repeatable procedure for Corrective and Preventive Action (CAPA) is a key FDA requirement for medical...

4 min read

What is FDA 21 CFR Part 11?

FDA Compliance

What is 21 CFR Part 11? FDA requirements explained

WTH is FDA 21 CFR Part 11? That’s a question many medical device developers wanting to access the US market mu...

5 min read

FDA 510K vs PMA

FDA Compliance

The FDA submission process: 510K vs PMA. What’s the difference?

How can medical device developers gain FDA approval for their devices and permission to sell their product int...

4 min read

FDA logo

FDA Compliance

How can you get your FDA 510(k) submission right first time?

Developers who want to release a medical device in the US need to seek permission from the FDA. Depending on t...

4 min read

ISO 9001:2015 FDA Compliance Document Management and Control

What is a document control system and why is it important?

Having a document control system in place is a requirement of quality standards and regulations around the wor...

6 min read

DHF DMR DHF medical device requirements

Medical Device Development FDA Compliance

DHF, DMR and DHR. Demystifying FDA medical device development requirements

DHF, DMR, DHR… to the uninitiated they might sound like out-of-town furniture stores or airport codes for exot...

4 min read

Medical Device Development FDA Compliance ISO 13485:2016

Implementing Medical Device Design Controls for ISO 13485 and FDA 21 CFR 820

30 years ago the FDA introduced robust new requirements for medical device design control following a string o...

5 min read

e-Signature

FDA Compliance

A 21 CFR Part 11 checklist: 7 key FDA e-signature requirements

How does your organisation authorise, authenticate, document and police the use of electronic signatures withi...

4 min read

Med tech investment-bionic pig

Medical Device Development FDA Compliance

Bionic pigs are not enough. How to win med-tech investment if you're not Elon Musk

When Elon Musk unveiled his ‘bionic pig’ in an on-line event in September there was much hype and more than a ...

3 min read

Digital Signature MHRA Remote Working

Medical Device Development Compliance FDA Compliance

Digital Signatures: New MHRA guide clarifies remote approval requirements

A lot of us have been challenged by remote working lately, whether it’s the back ache acquired from working on...

4 min read

Good Documentation Practice for CBD industry

Quality Management System FDA Compliance

CBD, GMP and GdocP; quality management in the cannabis industry

Around the world different rules apply for the cultivation, manufacture and sale of cannabis and CBD products....

6 min read

How to talk to the FDA

FDA Compliance

How to talk to the FDA

I am a former FDA staff member and now back in the private sector. If you are in Regulatory Affairs, you are i...

2 min read

FDA prioritising Proactive Quality Management System

Product Management Compliance FDA Compliance

Why the FDA want Proactive Quality Management Systems

Reports from the U.S. tell us the FDA is continuing to prioritise Proactive Quality Management in the medical ...

3 min read

Digital Signatures

Compliance FDA Compliance

How digital signatures can help secure regulatory compliance

Digital signatures are proving valuable tools for businesses developing products for release in highly regulat...

3 min read

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