BSI's Meet the Experts - MedTech Edition

We are pleased to invite you to our in-person BSI Meet the Experts 2024 – MedTech Edition event on 11 September 2024 in Amsterdam, fully dedicated to the EU MDR. While the MDR deadline of May 26 2024 has passed, there are still many questions and challenges for the MedTech industry facing the difficulties of implementing the new regulation and the impact it has on the medical device industry. BSI is here to help you navigate the highly regulated EU MedTech sector. We have developed a dedicated event where you can explore and learn about the in and out of the MDR process from a Notified Body’s perspective. From application through conformity assessment, technical documentation, artificial intelligence, Article 117, Software as a medical device and many more.

Join this extended event to hear about the latest MDR regulatory environment for a Notified Body, IEC 60601 testing, clarification on specific MDR requirements and innovations to technical documentation submission, how to work with a Notified Body, article 117 for pharmaceutical companies, software as a medical device, artificial intelligence in medical devices and much more. Besides this is a unique opportunity to meet and connect with our MDR experts and our commercial team to address your MDR challenges and key questions. 

The meeting will be preceded by a Get Together session on 10 September, 18:00-20:00 CEST where you can interact with all our speakers, so please join us.

Agenda

Dates

• 10 September 2024: Reception - Get together session (18:00-20:00 CEST)
• 11 September 2024: Meet the Experts Event (09:00-17:00 CEST)

Event location

Van der Valk Hotel Zuidas, Tommaso Albinonistraat 200, 1083 HM, Amsterdam. See on map.

Registration fees

€100 per person (incl. VAT)

Note: In case of cancellation the Eventbrite admin fee will still apply.

Derek has had several commercial and project management roles at Bureau Veritas and TÜV Rheinland in the assurance, inspection, product testing arena. He joined BSI in 2015 bringing regulatory & commercial expertise and passion for sales & customer satisfaction to the organization. In the years at BSI Regulatory Services he has been part of the commercial team in Europe supporting the industry and clients in their transition to MDR compliance which is now followed with the coming AI Act which as well impact a part of the medical device industry.    

Thomas Doerge has an in-depth knowledge of Biomedical Engineering, Biomedical Microsystems and Medical Engineering & Neuroprosthetics, which includes micro-structuring, manufacturing, wireless energy and signal transmission, as well as the manufacturing and characterization of active implantable systems. He leads a global team of 24 Product Technical Specialists and dedicated clinical experts who are not just experienced in the regulatory process, but are product experts who understand the specifics of active implantable products.

Prior to his role at BSI, Richard worked as a clinical physiologist for 16 years within the National Health Service (NHS) specializing in implantable cardiac devices and electro physiology.

Richard joined BSI in 2018 bringing his clinical expertise and passion for clinical data to the organization. Richard is also involved with the working groups of the Medical Device Co-ordination Group (MDCG) for the EU.

Alex Zaretsky is an entrepreneur with a PhD in AI-enabled medical devices  and an Executive MBA, has a career spanning over a 14 years in startup innovation, AI-medical strategy development and regulatory fields. He excels in leading high-impact projects and building dynamic, growth-oriented teams, utilizing Lean and Agile methodologies to navigate the evolving tech and regulatory landscapes. His expertise includes launching and scaling AI-medical startups, securing funding, and ensuring compliance with quality and regulatory requirements. Currently Alex is an AI Regulatory Lead in AI Notified Body.

Theresa Jeary holds a master’s degree in Pharmaceutical Science from the Royal College of Surgeons, Ireland and is eligible to be a Pharmaceutical Qualified Person. 

Theresa has over 30 years’ experience working in both the Pharmaceutical and Medical Device industries and has worked in a variety of roles across the full development cycle from product concept and early-stage development, process transfer, validation and regulatory departments. 

In addition to her product development and global regulatory expertise, Theresa has over 12 years Notified Body experience, first at BSI as a technical expert for devices with ancillary medicinal substance and borderline classifications, moving then to LRQA where she held the role of Head of Notified Body for several years.  Theresa re-joined BSI in August 2020 working as a technical specialist in the Medicinal and Biologics Team.

Sreenath, a medical device professional with over 15 years of experience, brings a wealth of knowledge to the field. His expertise spans regulatory & clinical compliance, safety certifications, and the entire active medical device lifecycle, further strengthened by a master's degree in Embedded Systems and a specialized Diploma in Medical Electronics.

For the past 5+ years, Sreenath has leveraged his skills at BSI, auditing medical device regulations and directives within the EU and the UK. He is a recognized expert in software evaluations and IEC 60601 safety standards, with experience extending to medical device design and manufacturing. His commitment goes beyond his current role, through his participation on national and international committees dedicated to advancing medical device standards, including the UK National Standards Body and the IEC working groups for the IEC 60601-1 4th Edition.

Ingeborg joined BSI in 2018, she is currently the Business Development Manager for Benelux, Denmark and Iceland. Ingeborg is bringing her regulatory & commercial expertise and passion for sales, patient safety & customer satisfaction to the organization. Ingeborg has solid knowledge of the Medical Devices & AI industry and understands the complexity of both fields. Whether you are starting the certification process, looking to transfer or just need to discuss options for your business, Ingeborg can help you to understand the process.