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MDR

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 […]

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 […]

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 […]

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 […]

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 […]

Medical Device Regulations

The Medical Device Regulations – What You Need To Know

Change is the only constant in the life sciences sector and the introduction of the new medical device regulations in […]

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 […]

Understanding MDR: 8 Important Changes

The advent of the new Medical Devices Regulation (MDR 2017/745) in May 2020 is a cause of much concern for […]

Authorised Representative EUDR New EU Medical Device Regulations_ The Impact for Economic Operators

Brexit & Notified Bodies – What Are The Implications for the Medical Devices Sector?

The implications of Brexit will, possibly, be felt most in the area of Notified Bodies.  The UK’s exit from the […]

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