LRQA MDR and IVDR On-demand Webinars

Overview of changes & priorities initiated by the new MDR and IVDR requirements

The new Medical Device Regulation (MDR) and In Vitro Diagnostic Device Regulation (IVDR) replace the existing Medical Device Directive (MDD) 93/42/EEC and In Vitro Diagnostic Device (IVD) Directive 98/79/EC.

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During these webinars, experts from LRQA discuss the current status of the new Regulations, the transition period for manufacturers and the expected ‘Entry into Force’. The webinars offer a comprehensive overview of the key changes which will affect all Medical Device and In-Vitro Diagnostic Medical Device manufacturers, as well as the priorities for the different authorities.

About LRQA

As a leading Notified Body with more than 20 years’ experience in the medical arena, LRQA is actively shaping the medical directives and associated harmonised standards through our experts’ participation in the Medical Device Directive (MDD) and In Vitro Diagnostic Device Directive (IVDD) technical committees and associations, such as European Forum of Notified Bodies Medical Devices (NB-MED) and British In Vitro Diagnostics Association (BIVDA).

LRQA also provides input to regulators such as the Medicines and Healthcare Products Regulatory Agency (MHRA) the UK which reflect the concerns of our clients. LRQA is currently working towards having a full scope as a Notified Body under the new MDR and IVDR.

MDR Webinar

On-demand
Registration: Free
Duration: 45min followed by 15min Q&A
Speakers: Martin Penver and Theresa Jeary 


Overview 

  • EU Referendum 
  • Negotiations – Latest state of play 
  • What’s new? Key changes in MDR from current Directives 
  • Implementation – Timescale & Challenges

IVDR Webinar

On-demand
Registration: Free
Duration: 45min followed by 15min Q&A 
Speakers: Nick Baker and Ian Carmichael 


Overview

  • EU Referendum
  • Negotiations – latest state of play
  • What’s new? Key changes in IVDR from current Directives
  • Implementation – Timescale & Challenges

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.

IVDR Webinar Speakers

Nick Baker, LRQA Technical Manager – IVD Medical Devices

Image - Nick BakerNick has worked with LRQA for more than 15 years. As LRQA’s Technical Manager for IVD Medical Devices, he is responsible for the evaluation and assessment of technical documentation and certification decisions. He is the Chair of the Notified Body Recommendation Group and a member of Notified Body IVD working group, as well as a speaker at Informa and Q1 conferences on regulatory issues.


With more than 27 years’ experience in Medical Devices, Nick has prior worked as Scheme Manager for IVDs at BSI. He has extensive experience in IVD industry and was responsible at Anagen for managing a laboratory for routine production of hormone immunoassays and for viral immunoassays as a Team Leader at Murex Diagnostics.

Nick has knowledge of clinical chemistry and infectious disease, production and design of immuno-assays, and process validation. He holds a BSc in Biochemistry & Physiology from the University of Westminster and a MSc in Medical Biochemistry from Brunel University.

Ian Carmichael, MSc, FIBMS - IVD Technical Specialist

Image - Ian CarmichaelIan Carmichael joined LRQA in 2011 as the IVD Technical Specialist. Ian is responsible for managing the batch verification process for high-risk reagents, reviewing Design Dossiers and Technical Files for new products and re-approvals. He is LRQA’s product expert for blood grouping reagents, and specialist reviewer for IVD Directive Annex II List A Reagents, Medical Device Software as well as Blood Glucose Monitoring Systems.

Ian stared his career as a Biomedical Scientist within the NHS and then spent over 20 years in the manufacture of in vitro diagnostic reagents, holding various positions in internationally operating organisations ranging from Quality Control Scientist to Director of Quality and Regulatory Affairs. During this time, Ian has gained a thorough understanding and extensive implementation experience of the regulatory requirements for worldwide registration of Medical Devices.

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