Medical Devices

EU Medical Device Vigilance Reporting PART 2

EU Medical Device Vigilance Reporting: FAQ

In our first article surrounding EU Medical Device Vigilance Reporting, we discussed medical device vigilance reporting requirements for IVD and… Read more

EU Medical Device Vigilance System

EU Medical Device Vigilance Reporting

All medical device manufacturers are required to have an effective system for the review and evaluation of customer complaints. The… Read more

MDR-Essential Guide 2021

MDR: An Essential Guide for 2021

We published our first essential guide to MDR in 2020. Since then, the new MDR regulation has been introduced. This… Read more

Conformity assessment routes

Conformity Assessment Routes Under MDR 2017/745

As part of our ongoing review at the changes introduced with MDR, in this article we focus on Conformity Assessment… Read more

post market surveillance

Post Market Surveillance under MDR

Regulation (EU) 2017/745 on medical devices (MDR) has established specific requirements which focus on how manufacturers should establish and maintain… Read more

PRRC

PRRC: Person Responsible for Regulatory Compliance

This revised article concentrates on the role of the Person Responsible for Regulatory Compliance (PRRC). The role of QP is a… Read more

EUDAMED Registration-2021

EUDAMED Registration: Download our slide deck

With the introduction of the new Medical Device Regulations (MDR) since May 2021, we have noticed many new processes and… Read more

How do UDI's work-2020

How Unique Device Identifiers Work

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

what is a medical device

What is a Medical Device under MDR 2017/245?

We first published this article in 2020. This revised article considers the definition of a medical device and explore the… Read more

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