Medical Devices

Steps to CE Marking an IVD Medical Device

Steps to CE Marking an IVD Medical Device

One of the most frequent questions we are asked is: how do you CE mark an IVD device?  In this… Read more

Most Read Medical Device Articles of 2019

2019 has been a busy year for people involved in the medical devices sector.  The imminent arrival of MDR, on… Read more

2nd MDR whitepaper from Acorn Regulatory

2nd MDR Whitepaper: Get An Advance Copy

We will be publishing our 2nd MDR whitepaper ‘Be Prepared’ in October.  You can sign up to receive a copy… Read more

No Deal Brexit Planning from Acorn Regulatory

No Deal Brexit Planning – What We Know So Far

The ongoing coverage of the UK’s moves towards leaving the European Union continues.  This is a difficult time for companies… Read more

Device Vigilance System Update - Details from Acorn Regulatory

Device Vigilance System Additional Guidance: An Update from Our Devices Team

While much of the medical device industry is focused on MDR, the MDD is still in effect.  Bronwyn Kelly from… Read more

LRQA medical device

Impacted By The LRQA Decision? Here Is How We Can Help

The decisions by Lloyd’s Register Quality Assurance (the LRQA) and QS Zurich that they will both will cease to offer… Read more

Understanding MDR The Role of the PRRC Responsible Person

The 5 Responsibilities of the Person Responsible for Regulatory Compliance (PRRC) under MDR

As part of our series of articles looking at some of the changes on the way for medical device regulation… Read more

Selected Writing 2019 Ebook

‘Selected Writing from Acorn Regulatory’ Download It Here

‘Selected Writing from Acorn Regulatory’ highlights just some of the most read articles written by our expert staff in the… Read more

Medical Device Regulations

The Medical Device Regulations – MDR – What You Need To Know

The introduction of the new medical device regulations in May 2020 will bring significant changes to the way that we… Read more

Contact us and enjoy a faster, smoother journey through the maze of European Pharmaceutical and Medical Device legislation with us as your expert guide.
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