What is the webinar about?
This webinar will help manufacturers stay ahead of their technical and clinical reviews by providing direct insight from the Notified Body, which will streamline their MDR and IVDR reviews.
- Learn how to confidently navigate common hurdles in Technical and Clinical reviews.
- Understand how early engagement with Structured Dialogue provides predictability and pulls in the timeline of reviews.
- Get the most out of Dedicated Interactive reviews
- Framework: Early Engagement, Predictability, Shorter Review Process.
- Focused Q&A Time: Get your questions answered “live” by the Notified Body, BSI.
Who should attend?
Designed for medical device and IVD manufacturers working with BSI on MDR, IVDR, and UKCA applications, transfers, and surveillance.
What will participants gain?
Participants will gain direct feedback from the Notified Body on common pitfalls that delay reviews and raise costs, while learning how Structured Dialogue and Dedicated Interactive reviews can fast-track your submissions.
Speakers
Tamara
Widenhouse
Technical Team Manager, Vascular
Tamara has over 25+ years experience leading technical scientific and product development teams by exceeding expectations in new product development, scientific, technical and people leadership roles. In 2018, she joined BSI Group as a Technical Specialist and Scheme Manager on the Vascular Team specializing in Electrophysiology (Ablation for treatment of Atrial Fibrillation) and Neurovascular devices and was promoted to Technical Team Manager in 2021. Currently the Vascular Team consists of more than 40 Technical and Clinical Experts covering product specialties ranging from high-risk Class III Implantable vascular devices such as stent grafts, heart valves, stents and embolization devices to non-implantable surgical catheters, guidewires, balloon catheters and electrophysiology devices
Kevin
Madden
Head of Professional Development
Kevin is an experienced leader in the medical device industry, bringing over 20 years of international experience across research & development, professional development, and regulatory affairs. As Head of Professional Development for Regulatory Services at BSI, Kevin leads the design and delivery of impactful learning and development (L&D) programmes, technical training events, and continuous professional development initiatives for professionals in medical devices, AI, and product certification.
Diego
Falletti
Regulatory Lead
Diego has been with BSI for over 9 years and currently serves as Technical Team Manager within the Vascular Team. He brings more than 15 years of expertise in the medical device industry, with a strong background in the design and development of endovascular devices. At BSI, Diego leads a team of scheme managers, technical specialists, and clinical evaluation specialists, overseeing competencies in CE marking under both EU MDR and MDD, as well as UKCA marking and ISO 13485 compliance.
Email: medicaldevicesmarketing@bsigroup.com
Phone: +44 3450809000
