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Regulatory Affairs, Medical Devices

Notified Body designation and scope, the impact of Brexit and Competent Authority and Notified Body interpretation of the regulations. Make sure you are up to date!

Articles & Video

Showing 21 of 51 articles & video
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EU MDR

Data Report: Implementation of EU MDR

This MedTech Series report looks at post-EU MDR implementation data based on analysis of of a research study across medical device professionals.
MedTech

Implementation of EU MDR | MedTech Series eBook

Following the implementation of the EU MDR in May 2021, this MedTech Series eBook answers a number of questions organizations are still struggling with.
COVID-19

REPORT: COVID-19 One Year On - Impacts on the Global Life Sciences Industry 2021

EU IVDR

REPORT: EU IVDR State of the Industry 2021

Explore our exclusive report on the EU IVDR State of the Industry 2021 based on over 100 survey responses.
COVID-19

Life Sciences Survey: COVID-19 Impacts One Year On

Take part in our industry survey on the impacts of COVID-19 on the life sciences one year on to get exclusive early access to the final report.
IVDR

Survey: EU IVDR State of the Industry 2021

EU IVDR State of the Industry: Take part in our survey to get exclusive early access to the final report.
PRRC

Your Questions Answered: Understanding the role of Person Responsible for Regulatory Compliance

The TEAM-PRRC EU Association answer your questions on understanding the role of Person Responsible for Regulatory Compliance (PRRC) under the EU MDR.
Diversity and Inclusion

REPORT: Diversity, Equity and Inclusion in the Life Sciences 2021

Explore the Diversity, Equity and Inclusion in the Life Sciences 2021 report based on an exclusive study of 483 industry professionals.

Clinical expectations of the EU MDR with TÜV SÜD and MedSmart

Clinical expectations of the EU MD: Matthias Fink from TÜV SÜD, and Dona Occhipinti from MedSmart discuss in this exclusive video interview.
EU MDR

The Journey to EU MDR Implementation - MedTech eBook Series

We answer some of the questions around EU MDR implementation in this MedTech Series eBook.
Medical Device

How the changing EUDAMED timeline impacts implementation of the EU MDR - with Eudamed.eu CEO Richard Houlihan

Richard Houlihan, CEO of EUDAMED.EU, discussed the EUDAMED modules status and the impact on implementing the EU MDR in this exclusive interview.
Diversity and Inclusion

SURVEY: Diversity, Equity and Inclusion in the Life Sciences 2021

Complete our survey on Diversity, Equity and Inclusion in the Life Sciences 2021 to get exclusive early access to the final report.

Changes to the ISO 10993-23 and its impact on the medical device industry with NAMSA

Don Pohl from NAMSA discusses the changes to ISO 10993-23 in vitro guidance and what it means for the medical device industry.
MedTech

EU Notified Body Association Takes Steps to Allay EC's Virtual Audit Fears

Amanda Maxwell looks at how the EU Notified Body Association is helping allay virtual audit fears.
EU MDR & IVDR

MDR and IVDR: Onsite or offsite audits? That’s the question.

We examine the latest requirements with regard to Notified Bodies’ audits performed in the context of quality management system (QMS) assessment.

EU IVDR Preparation and Implementation - MedTech eBook Series

EU IVDR Preparation and Implementation: Discover Industry, Notified Body and Competent Authority perspectives in this MedTech Summit eBook.
MedTech

REPORT: Adoption of AI and Digital Solutions in the MedTech Industry

This exclusive report looks at how AI and digital solutions have been adopted in the MedTech industry, and what the future looks like.
MedTech Summit

MedTech Summit 2020 Post-Event Report

Find the latest on EU MDR, IVDR and medical device law in this MedTech Summit 2020 Post-Event Report.
Regulatory Information Management

Is your Regulatory Information Management process putting your company at risk?

Many companies are putting themselves at risk lacking AI -powered RIM systems for regulatory data management. Get the details in this complimentary article.
Survey

Survey: Adoption of AI and Digital Solutions in the MedTech Industry

Take part in our study to discover the adoption of AI and digital solutions in the MedTech industry.
MedTech eBook Series

Clinical Evaluations for Medical Devices and IVDs - MedTech eBook Series

Discover how the EU MDR will affect clinical evaluations for medical devices and IVDs in this MedTech Summit eBook.

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