DMS Insights from Cognidox | FDA Compliance

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

Why not use Microsoft software to build your own digital QMS?

SMEs creating a digital Quality Management System (QMS) often turn to familiar, digital tools to build a solut...

5 min read

Medical Device Development Glossary A -Z

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...

13 min read

FDA PCCP

The FDA Predetermined Change Control Plan: What you need to know

Documentation continues to be of vital importance to medical device development in the age of AI. One example?...

3 min read

QMSR transition

FDA QMSR Compliance: Are you ready for 2026?

From February 2, 2026, all medical device manufacturers and importers selling their products in the USA will n...

4 min read

Ai in medical devies

AI in Medical Devices: Navigating the Regulation in the US, UK, and EU

The integration of Artificial Intelligence (AI) into medical devices represents one of the most promising yet ...

4 min read

FDA CAPA

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...

5 min read

What is FDA 21 CFR Part 11?

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 Regulation Update: QMSR and ISO 13485:2016 Explained

In February 2024, the FDA published its final rule for the new Quality Management System Regulation (QMSR). So...

5 min read

QSR COMPLIANCE_FDA 21 CFR Part 820

GxP FDA Compliance

FDA 21 CFR Part 820 Explained: QSR Requirements & Guide

If you’re developing or manufacturing medical devices in the U.S., complying with FDA 21 CFR Part 820—also kno...

6 min read

Person using software as medical device

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

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 510K vs PMA

FDA 510(k) vs PMA: What’s the Best Path for Your Device?

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

4 min read

FDA 510(k) Submission Tips for Medical Device Developers

To launch a medical device in the US, developers must gain FDA permission. For most Class II devices, this inv...

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 21 CFR Part 11: 7 E-Signature Requirements For Medical Device Developers

Are your e-signatures compliant with FDA 21 CFR Part 11? For medical device developers, ensuring your electron...

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, GDocP, and Compliance

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

How to Communicate with the FDA: 10 Insider Tips for 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

FDA Expectations for Proactive Quality Management for Medical Devices

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

FDA-Compliant Digital Signatures: Why They Matter for MedTech

For companies operating in highly regulated sectors like medical devices, biotech, and pharma, digital signatu...

4 min read

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