The New Medical Device Regulation (MDR) - Frequently asked questions

MDR FAQsDo you have questions around the new MDR expected to be published in Q2 2017? Regulatory affairs professionals and device manufacturers are looking for answers and solutions on how to implement the new requirements. Two of LRQA’s top medical device technical experts have teamed up to answer some of the most frequently asked questions concerning this new regulation.

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About Theresa Jeary

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Theresa Jeary has over 25 years’ experience in the medical device and pharmaceutical industries as well as Notified Bodies. She is currently responsible for managing the team of product experts and is a Certificate decision maker at LRQA. A well-known expert within the device and drug product arena, Theresa is a regular speaker at international regulatory conferences and seminars.

Theresa’s background includes the development and commercialization of woundcare devices utilizing animal tissue as well as various devices across a broad scope incorporating ancillary medicinal substances. Theresa also has extensive Quality Management System expertise, including maintaining ISO 13485 certification and Good Manufacturing Practice for medicinal products. Theresa holds a Master’s Degree in Pharmaceutical Science from the Royal College of Surgeons, Ireland, and is eligible to be a Pharmaceutical Qualified Person. She is an active member of The Organization for Professionals in Regulatory Affairs (TOPRA) SPIN Committee for Medtech, and regular contributor to Regulatory Rapporteur magazine.

About Martin Penver

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Martin Penver leads LRQA’s medical devices team as Head of Notified Body. Martin has 16 years of experience within the medical device industry, and is also a trained ISO 13485 lead auditor Prior to joining LRQA as Operations & Technical Manager in 2012, Martin spent six years at other Notified Bodies. Martin’s background includes product expertise on vascular therapies where he has been responsible for evaluating and assessing technical documentation, and shape memory alloy processing involving the development and manufacturing of stent positioning systems for renal and coronary arteries.