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What is FDA 21 CFR Part 11?

FDA Compliance

Understanding FDA 21 CFR Part 11: A Guide for Life Science Developers

WTH is FDA 21 CFR Part 11? That’s a question many life science developers wanting to access the US market must...

5 min read

Deviation management pharma industry

GxP Compliance FDA Compliance

5 Challenges in Building a Pharmacovigilance System Master File

Managing the integrity and accessibility of a PSMF (Pharmacovigilance System Master File) is a key challenge f...

5 min read

QMSR vs ISO 13485

FDA Compliance

FDA Regulation Update: QMSR and ISO 13485:2016 Explained

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

Mastering Medical Device Development: An A-Z Guide of Acronyms

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

Demystifying FDA 21 CFR Part 820: A Comprehensive Guide

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

Building Your Digital QMS: Is Microsoft Software the Right Choice?

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

FDA CAPA Requirements: Ensuring Compliance and Quality Control

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

4 min read

FDA 510K vs PMA

FDA Compliance

Navigating FDA Approval: Understanding 510K vs PMA

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

Tips for a Successful FDA 510(k) Submission: Get It Right

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

4 min read

DHF DMR DHF medical device requirements

Medical Device Development FDA Compliance

Understanding FDA Medical Device Development Requirements: DHF, DMR, DHR

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

Streamlining Medical Device Design Controls for FDA and ISO Compliance

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

7 Key FDA E-Signature Requirements for Medical Device Developers

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

Navigating the Med-Tech Investment Landscape: 5 Tips for Success

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

MHRA Guide: Remote Approval Requirements for Digital Signatures

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

Quality Management in the CBD Industry: GMP and GdocP Explained

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

Navigating FDA Interactions: 10 Tips for Regulatory Success

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

The FDA's need for Quality Management in Medical Device Development

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

Securing Regulatory Compliance: The Power of Digital Signatures

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

3 min read

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