Acorn Regulatory’s Top 100 Articles

Medical Device Post-Market Obligations, a European Perspective: Part 2 – Assessing Product Changes

Last week, in the first part of this series, we outlined the post-market obligations for Manufacturers under the European IVD and… Read more

Medical Device Post-Market Obligations – a European Perspective: Part 1 – Post-Market Surveillance

Under the European IVD and medical device directives, once a Manufacturer has CE marked their device and placed it on… Read more

Conducting Internal Audits – Guidance from our Quality Team

Our quality team has a well deserved reputation for excellence.  In this blog they share their thoughts on what you need… Read more

EU Medical Device Vigilance Reporting: Part 2 – Frequently Asked Questions

  In part 1 of this series we gave you a quick overview of the medical device vigilance reporting requirements for IVD… Read more

EU Medical Device Vigilance Reporting – Part 1 – ‘The Abridged Guide’

If you are a manufacturer of an IVD or a medical device, once your product is on the market, you… Read more

Do You Want To Find Out About CE Marking An App? Find Out More Here

There has been a veritable explosion in the number of mobile apps which act as aids to patients and clinicians… Read more

New European Medical Device and IVD Regulation – Where is it?

The long anticipated wait for agreement and adoption of the new European Medical Device and IVD Regulations will go on… Read more

Borderline Medical Devices Covered in EU Manual Update

With the rapid development of new software tools and mobile apps in healthcare, questions arising over classification will become increasingly… Read more