Navigating Regulatory Requirements for Medical Devices

As medical devices and laboratory equipment grow increasingly complex, rigorous testing and certification have become essential to support safety, performance and regulatory compliance. Keeping up with frequent regulatory updates and adapting to connected, evolving technologies is vital for delivering safer, more effective patient care.

However, navigating regulatory requirements across different markets can be challenging due to varying transition periods and timeframes.

We’re pleased to invite you to our seminar, “Navigating Regulatory Requirements for Medical Devices.”

Gain valuable insights on:

Overview of IEC 60601-1, Medical electrical equipment and IEC 61010-1, Safety requirements for electrical equipment for measurement, control, and laboratory use

Choosing between IEC 60601-1 and IEC 61010-1

Guide to usability standards: IEC 60601-1-6 and IEC 62366 Part 1: Application of usability engineering to medical devices

Learn about IEC 60601-1 Clause 14 and IEC 62304 Medical device software – Software lifecycle processes

Key changes in ISO 14971 Medical devices – Application of risk management to medical devices

Overview of conformity assessment submissions

Overview of the EU Medical Devices Regulation (MDR 2017/745)

EU MDR requirements for products and technical documentation

Manufacturer and Authorized Representative responsibilities

Identification of EU Notified Bodies and notification

EU classification and conformity assessment routes for medical devices

Speakers

Yeoh Wei Yee, business manager, UL Solutions

Sreenu Sattu, manager, Quality & Regulatory Affairs program, Emergo by UL