Bronwyn Kelly

Conformity Assessment Routes Under MDR 2017/745

As part of our ongoing look at the changes being brought about by MDR, we look at Conformity Assessment routes… Read more

Post Market Surveillance part of the Acorn Regulatory series on MDR

Post Market Surveillance under Medical Device Directive (2017/745)

Regulation (EU) 2017/745 on medical devices (MDR) now has increased requirements on specific Post Market Surveillance (PMS) and Post-market clinical… Read more

MDR Whitepaper 3 from Acorn Regulatory

Download the 3rd Acorn Regulatory MDR Whitepaper

The 3rd Acorn Regulatory MDR whitepaper is available now.  This publication looks at Clinical Evaluation Reports, Conformity Assessment Routes and… Read more

Unique Device Identifiers MDR Acorn Regulatory

How Unique Device Identifiers Will Work Under MDR

The Unique Device Identifiers system under the Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 IVDR apply new requirements on… Read more

2nd MDR whitepaper from Acorn Regulatory

2nd Acorn Regulatory MDR Whitepaper: Be Prepared for May 2020

Our second Acorn Regulatory MDR whitepaper looks at the issues of unique device identifiers, the role of Eudamed under MDR… 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

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

Acorn Regulatory has published its first medical device regulations (MDR) whitepaper.  The whitepaper looks at a range of issues. Get The Acorn Regulatory Medical Device Regulations Whitepaper

Get The Acorn Regulatory Medical Device Regulations Whitepaper

The new medical device regulations (MDR) will come into force in May 2020.  In advance of the deadline, companies across… 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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