MDRChats-by ChatMDR

In this episode, Oliver Harris discusses the newly published guidance document MDCG 2024-13 with a regulatory expert. The document, titled 'Regulatory Status of Ethylene Oxide (EtO) Intended for the Sterilisation of Medical Devices - October 2024,' provides guidance on the use of ethylene oxide in the sterilisation process of medical devices under the Medical Device Regulation (MDR).

In this episode of MDRChats, host Oliver Harris interviews medical device compliance expert Dr. Emma Lawson to clarify the differences between Annex 9, Annex 10, and Annex 11 under the Medical Device Regulation (MDR). They delve into the various conformity assessment options, discuss how manufacturers can decide which route to take, and shed light on this often confusing topic for professionals in the industry.

In this episode of MDR Chats, host Oliver Harris interviews an expert about the MDCG 2023-7 guidance document. They discuss the concept of ‘sufficient levels of access’ to data needed to justify claims of equivalence for medical devices, exploring the types of data required, methods of demonstrating access, and the implications for manufacturers. This episode provides essential insights into ensuring compliance with EU medical device regulations and maintaining high standards of safety and performance.

Join host Oliver Harris on MDR Chats as he interviews industry expert Dr. Emily Thompson about the latest revisions in standardisation for medical devices. Stay updated with essential insights on the new MDCG document published in July 2024, including key differences and implications for compliance in the medical device sector. Tune in for expert guidance and practical advice.

Join host Oliver Harris on MDR Chats as he interviews industry expert Dr. Emily Collins about the clinical evaluation of orphan medical devices. Discover the unique challenges and considerations in developing, testing, and regulating devices for rare conditions. Perfect for professionals and enthusiasts in the medical device field.

A risk-based statistical sampling plan for medical devices adjusts sample sizes and testing criteria according to the potential impact of failures, guided by historical data and risk assessments. This method efficiently ensures product safety by matching testing intensity to the severity of possible risks

In this podcast, regulatory experts discuss the extended deadlines under the Medical Device Regulation (MDR), focusing on the transitional periods for various classes of medical devices.

In this episode of MDR Chats, we delve into the intersection of artificial intelligence and medical device regulation under the new EU Artificial Intelligence Act.

This episode is created by chatMDR.eu .

The voices in this podcast are AI-generated.

Better understanding of the PRRC's role, responsibilities, and operational considerations for manufacturers and other economic operators.

The voices in this podcast are AI-generated.

MDRChats is your go-to podcast for the latest insights and updates on Medical Device Regulation, tailored for those with busy schedules.

Our episodes are designed to enhance your understanding of MDR, keeping you informed and ahead in a rapidly evolving field. Subscribe to MDR Chats and effortlessly learn more about Medical Device Regulation.