Stay Compliant: Medical Device Industry 2024 Regulatory Update

Webinar Overview

Our latest Medical Device webinar will take an in-depth exploration of the global medical device regulatory landscape and provide a concise overview of the key regulatory developments in the last several months in 2024 to help you understand the important regulatory changes in the medical device industry.

In the EU, in 2023, Regulation EU 2023/607 entered into force, extending the transitional provisions of the MDR under certain specific conditions. This webinar examines those timelines as well as those proposed for the IVDR. In addition, the webinar will examine the recent changes to the UK medical device framework. The webinar will also examine the impact of the EU Artificial Intelligence Act on the medical device industry, it will look at the recent FDA Quality Management System Regulation, as well as Brazil’s Normative Instruction 290/2024.

The webinar also covers other key regulatory developments in the rest of the world, so you can manage obligations impacting your business and stay ahead in today’s regulatory landscape.

Webinar Agenda

Our experts will be discussing the key regulatory developments such as:

• EU Regulation (EU) 2023/607 on the extension of transition timelines.
• EU Artificial Intelligence Act (AIA)
• UK framework for medical devices 
• New Zealand Therapeutic Products Act
• USA Quality Management System Regulation (QMSR) final rule
• Brazil Normative Instruction No. 290/2024 and the equivalent Foreign Regulatory Authority 
• Colombia Medical Device Policy 2024-2026
• And More…

Date

This webinar took place on Wednesday, 12th June 2024 at 08:00 PDT, 11:00 EDT, 17:00 CET.

Further regulatory developments may have occurred after publication. To keep up-to-date with the latest compliance news, sign up to our newsletter.

Presenters

Denise McDermott, Senior Regulatory Compliance Specialist

Denise McDermott is a senior regulatory compliance specialist on the Global regulatory compliance team at Compliance and Risks. Prior to this she worked in the medical device industry for 13 years across a number of areas including regulatory affairs, post-market surveillance, customer complaints, quality, and technical support.

Denise holds an honours degree in biochemistry and a Ph.D. in cancer biology.

Vish Karasani, Product Marketing Manager

Vish is a Product Marketing Manager at Compliance & Risks, with over 8 years of international experience working in highly competitive industries and at hyper-growth startups.

An avid storyteller, her product marketing philosophy begins with listening to Compliance & Risks’ customers, understanding their pain points, solving for their problems and building for their future.