MDR

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 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

Dekra has been chsoen as the 3rd notified body accredited under MDR

DEKRA Chosen As 3rd Notified Body Under MDR

DEKRA, the German based company, has been chosen by The European Commission as the third notified body to be accredited… 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

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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