6 May - 14:00 - 15:00 GMT / 15:00 – 16:00 CET
Innovative Medical Devices: How to Navigate the Regulated MedTech Landscape to Place These on the Market
Bringing an innovative medical device to market requires navigating complex regulatory pathways, while also ensuring compliance with evolving standards, and addressing key stakeholder expectations. This webinar will provide valuable insights into the challenges and opportunities in the MedTech regulatory landscape.
Through expert perspectives from a Notified/Approved
Body, a consultant, and a Medical Device Manufacturer, you will gain a
comprehensive understanding of the critical steps in achieving market access.
This session will cover best practices, common pitfalls, and real-world
experiences to help MedTech innovators successfully bring their products to
patients.
Learning Outcomes:
•
Understand the regulatory requirements and pathways for placing an innovative
medical device on the market.
•
Learn best practices for streamlining the regulatory approval process.
•
Hear real-world insights from industry experts and stakeholders.
Speakers:
Dr. Bassil Akra
CEO AKRA TEAM
Dr. Bassil Akra is CEO and President of AKRA TEAM in Germany (GmbH) and the USA (Inc), a globally acting consultancy company. Dr. Akra was the Vice President of Strategic Business Development at the Global Medical Health Services of TÜV SÜD Product Service GmbH. He has vast experience in leadership, business management, research, development, quality management, and regulatory approval of medical devices, combination devices, and ATMP Products. Dr. Akra played an essential role during the implementation of the medical device regulation in Europe. He was also involved in the drafting of several European guidance documents (e.g. MEDDEV, MDCG, etc.) and International Standards. He spent the last years of his career at TÜV SÜD training and educating various stakeholders on EU Legislations. Dr. Akra is also member of the Board of the EU Association TEAM PRRC. He is also member of the MDR EY Survey Advisory Group.
Vishal Thakker
Head of UK Approved Body & Senior Regulatory Lead, Regulatory Services (Medical Devices)
Vishal joined BSI over 9 years ago and is currently the Head of the UK Approved Body for Medical Devices and IVDs. He is responsible for the regulatory oversight of the Approved Body and wider BSI strategy, policies, procedures, and documentation to meet the various legislative and designation requirements. Prior to his current role, he has been a Regulatory Lead, Technical Team Manager, Technical Specialist & Scheme Manager with expertise in Active Devices. He holds a Masters in Medical Engineering from Queen Mary University of London and has over 10 years’ experience with medical devices working within industry, third party testing and Notified/Approved Body. Vishal is also co-president of Team-AB the association of UK Approved Bodies.
Dr. Nick Gompertz
Founder at Earswitch Ltd
EarSwitch™ have developed a suite of in-ear biometric control and sensor technologies for an ever-increasing range of global applications. Seeing people with motor neurone disease (ALS) lose their ability to communicate gave Nick the idea to develop a non-intrusive, in-ear device that could help people with neurological impairments choose how to live their lives.
From controlling devices by tensing a middle ear muscle, to recording real-world data from a site close to the eardrum, there's a lot of potential to be found within the ear. Potential that EarSwitch™ is using to create a new global standard of medical monitoring.
This webinar is sponsored by BSI
Disclaimer: Whilst TOPRA is running this webinar for BSI, this is not an endorsement of BSI, BSI's affiliates, employees or its products and services. TOPRA is also not responsible for the content or views expressed during the webinar.
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Pricing
- Members: free
- Non-members: free
Terms and Conditions
By purchasing this webinar, you are agreeing to TOPRA's training terms and conditions.