Blog Posts
Hear the latest thoughts and opinions of the quality and regulatory experts. Please click on an article below to learn more:
Six Regulatory Oversights that Kill Startups
Medical device startups have a tough time. Make it easier with these six top tips to avoid regulatory oversights and speed up submissions
Read MoreHow to Prepare for an Unannounced Audit
Dreaded by many, but easily survivable if you prepare well. Find out how in this article.
Read MoreHow to Feel Prepared for an Audit
Are you ‘patch-and-pray’, or would you rather have a considered approach to audit preparation, allowing everyone to feel as calm as possible?
Read MoreProcedure Packs – One of the Most Misunderstood Concepts in Medical Device Regulation
Almost everyone has seen a procedure pack – think of the archetypal first aid kit. However, a surprising number of procedure packs resemble Schrödinger’s Cat….
Read MoreFive Ways to Make a QMS Auditor’s Heart Sink.
Every QMS auditor has their top pet peeves…areas within QMS that their clients misinterpret or just really struggle to get their head around over and…
Read MorePreventive Action in ISO 13485: The Struggle is Real
I must confess upfront that this is a subject I am prone to soapbox rants about. Preventive action is one of the most consistently misunderstood,…
Read MoreInternal Audits vs Certification Body Audits: Why the Findings Never Match
Have you always wondered why your internal audits, be it ISO 9001, ISO 13485 or other standards, never seem to find the same things as your certification body? Then read on
Read MoreUnderstanding the EU MDR: A Practical Guide for Medical Device Startups
If you are a start-up founder trying to get a medical device to the European market, you have probably already encountered the EU Medical Device…
Read MoreSignificant Change: What Health Canada Got Right and the EU MDR Has Not Yet Managed
Health Canada has published the answer. The EU is still working on a consistent one. At the end of March 2026, Health Canada published the…
Read MoreUK Responsible Person (UKRP): What Overseas Medical Device Manufacturers Need to Know
If you are an overseas manufacturer with devices on the Great Britain market, or planning to enter it, February 2026 brought news worth paying attention…
Read MoreFrom Wild West to Watchdog: The Story of Own Brand Labelling and Why It Matters Again
The European Commission’s proposal COM(2025) 1023, published in December 2025, contains a lot of sensible ideas aimed at reducing the administrative burden on medical device…
Read MoreQMS Implementation for Medical Device Manufacturers: A Practical Guide
One of the more frustrating and unexpected aspects of working as an auditor is arriving at a company, seeing exactly what has gone wrong, and…
Read MoreISO 13485: Optional or a Necessity?
When I first started working in medical device regulation, the question of whether to pursue ISO 13485 certification rarely came up. Most manufacturers just did…
Read MoreDo You Need a Medical Device Regulatory Consultant? Here’s How to Tell
There is a very specific moment when most medical device manufacturers realise they need outside regulatory help. It tends to be quiet. Possibly awkward. Sometimes…
Read MoreThe MHRA’s CE Marking Consultation: Be Careful What You Wish For
The MHRA’s recent consultation on continued recognition of CE marking in Great Britain has produced a familiar mix of relief, frustration and a faint sense…
Read More
Welcome to Peritus Regulatory Consulting Ltd: Your No.1 Trusted Partner in Medical Device Compliance
Navigating the complex and ever-evolving regulatory landscape for medical devices can be daunting. Manufacturers, Certification Bodies, and Approved Bodies face constant challenges – from shifting…
Read More