Key Presentations at the Medical Devices & IVD Conference Released

LONDON - Aug. 17, 2022 - PRLog -- Launching for the first time in London, UK on 14 and 15 November will be the Medical Devices & IVD Conference. The conference will consider the evolving regulatory landscape for digital health software.

Interested parties can register at http://www.medicaldevices-ivd.com/PR2PRLOG  - register by 30 September to save £100.

SAE Media Group have released the key presentations that will be taking place at the Medical Devices & IVD Conference, see below for a snapshot:

Medical Device Development to Commercialisation: Collaborations & Regulations presented by Amanda Matthews, Senior Director, Pfizer which will cover:

• What are the biggest challenges when collaborating between medical device and pharma companies?
• What works well when collaborating across the whole lifecycle management?
• Clarification of fundamental terms to improve communication (between manufacturers, regulatory bodies, and pharma companies)
• Discussion of the impact of the EU MDR and IVDR and how collaboration can be improved to optimize processes

The IVDR: What Has Been Learnt So Far presented by Anne Whalen, Previously Director, Novartis, she will cover:

• Discussion of the current experience in the industry with the IVDR rollout
• Requirements for additional guidance in Europe and further IVDR interpretations
• Exploring the role of notified bodies with the EMA- what is this consultation process?
• Examining stakeholder challenges and relationships (NBs/manufacturers/ EMA)

EU MDR Clinical Aspects: Reviewing The Progress Of Implementation presented by Tom Melvin, Former Competent Authority Chair, Clinical Investigation & Evaluation Working Group, European Commission, this will focus on:

• Assessing the clinical aspects of the EU MDR and best practices for compliance
• Addressing the common challenges for new devices vs. legacy devices
• Looking into the future: gaps in current guidance and how to address this

Complying to the Medical Device Regulations: Strategies presented by Jim Leamon, Director, Jazz Pharmaceuticals, he will focus on:

• How can pharma companies work with notified bodies on endpoint expectations for MDR and IVDR compliance
• Defining the medical device product: what do I have?
• Medical device life cycle management
• The impact of implementing the new IVDR and combination product regulations and discussion of their strategies for expanding the QMS to meet manufacturer requirements

To find out more about the expert speakers joining the Medical Devices & IVD Conference, please visit: http://www.medicaldevices-ivd.com/PR2PRLOG