Medical Devices

medical devices regulatory affairs

Do You Want To Progress Your Medical Devices Career?

We are growing at a rapid pace at Acorn Regulatory.  Right now, we are seeking to hire a Senior Medical… Read more

Drug Device Combination Products Acorn Regulatory

Drug Device Combination Products: An Acorn Regulatory Overview

The European medical devices regulation (MDR) 2017/745/EC was published on 5th May 2017 and has updated significantly the requirements for… Read more

Clinical Evaluation Reports

How To Write An Effective CER

The clock is ticking for medical device manufacturers distributing in the European Union (EU). The EU is transitioning from the… Read more

Definition of a medical device

Definition of a Medical Device: Explainer

MDR 2017/245 covers devices that previously fell under two separate European directives, the Medical Devices Directive (MDD 93/42/EEC) and the… Read more

Regulatory Intelligence 8

Download ‘Regulatory Intelligence 8’

Edition 8 of the Acorn Regulatory whitepaper series ‘Regulatory Intelligence’ is out now and can be downloaded from our site. … Read more

The Risk Based Classification System Under IVDR 2017/746

One of the key changes in the new IVDR Regulation 2017/746, is the introduction of a risk-based classification system for… Read more

Understanding MDR The Role of the PRRC Responsible Person

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

This article is part of our series of MDR articles that look at the changes coming into play with the… Read more

Clinical Investigation MDR

Carrying Out A Clinical Investigation Under MDR

As part of our ongoing MDR series, we are looking at clinical investigations and how they will operate after the… Read more

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

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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