MDR Webinar - Overview of changes & priorities initiated by the new MDR requirements

The new Medical Device Regulation (MDR) will replace the existing Medical Device Directive (MDD) 93/42/EEC. The regulation are currently in their final stage of development and are expected to be published towards the end of Q1 2017. 

LRQA presents a comprehensive overview of the key changes which will affect all Medical Device manufacturers, as well as the priorities for the different authorities. During the webinar, LRQA experts also discuss the current status, the transition period for manufacturers and the expected ‘Entry into Force’ of the new Medical Device Regulation.

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MDR Webinar Speakers

Martin Penver, LRQA Technical Manager – Medical Devices

Image - Martin PenverMartin Penver has worked with LRQA since 2011 as Technical Manager for Medical Devices. He is the Head of Notified Body for Medical Devices for LRQA and responsible for the evaluation and assessment of technical documentation. Martin is a regular speaker at RAPS, ABHI and TRAC meetings on regulatory issues.

Martin has more than 16 years’ experience in Medical Devices and prior to joining LRQA, he worked as Vascular Product Specialist at BSI, as well as within the New Product Development and Manufacturing teams at Aspen.

Martin holds a Bachelor’s degree in Mechanical & Manufacture Engineering from the University of Coventry and a HNC/ONC in Mechanical & Production Engineering. He specialises in multiple areas including; complex technical medical devices such as coronary and peripheral balloon dilation catheters, ostial marking solutions with the cardiovascular, stents, and guide wire systems.

Theresa Jeary, LRQA Technical Manager – Medical Devices

Image - Theresa JearyTheresa Jeary has over 25 years’ experience working in the medical device and pharmaceutical industries as well as Notified Bodies. Theresa is well-known within the medical device and drug product arena, and is regularly asked to speak at international conferences and seminars about the regulatory requirements.

As LRQA Technical Manager, Theresa is responsible for the management of the conformity assessment process, device experts and CE certification decisions. Prior to joining LRQA in 2013, Theresa worked for BSI as a Certification Manager in the General Device group for five years.

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 also an active member of The Organisation for Professionals in Regulatory Affairs (TOPRA) SPIN Committee for Medtech and a regular contributor to Regulatory Rapporteur magazine.