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KI Science Park Lunch & Learn with BSI
How to best interact with a Notified Body for a successful MDR/IVDR application?
We welcome all MedTech and Diagnostics companies. If you are developing products for the European market. At this event you get the opportunity to meet BSI, one of the leading notified bodies. We will listen to Charlotte Hess, Senior Business Development Manager IVD EMEA North and Magnus Olla, Business Development Manager, Medical Devices – Nordics. They will share their insights on how to best interact with a Notified Body for a successful MDR/IVDR application.
AGENDA
11.45 – 12.00 Registration, lunch wraps served
12.00 – 12.05 Welcome and introduction by KI Science Park/ KI Innovations
12.05 – 12.40 Presentations by Charlotte and Magnus from BSI
12.40 – 13.00 Q&A and closing
13.00 – 13.15 networking
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13.15 – 14.00 by-invitation-only Q&A with BSI and companies part of KI Innovations incubator program DRIVE and STING The Q&A take place at KI Innovations office. An invitation will be sent to the companies concerned.
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BSI The Netherlands (2797) is a leading Notified Body; they review medical devices to ensure that they conform to the requirements of the European Directives and Regulations. BSI UK (0086) is a UK Approved Body able to provide conformity assessments under the new UKCA scheme. Their mission is to ensure patient safety whilst supporting timely market access to medical technology in a sustainable manner.
Magnus Olla – Business Development Manager, Medical Devices – Nordics
Magnus joined BSI in 2021, bringing with him 15+ years of commercial experience. He has worked in different roles within the regulatory industry, partnering with start-ups, consultants, global manufacturing, industry associations and hubs in the Nordic region.Solutions oriented, Magnus fosters collaboration through mutual trust and understanding. His knowledge and expertise are valued by clients and stakeholders alike.
In addition to medical devices, Magnus has a wealth of expertise covering quality management systems, supply chain development, risk management and testing
Charlotte Hess – Senior Business Development Manager IVD EMEA North
Charlotte has joined BSI in 2017. She’s is currently the Senior IVD Business Development Manager for Northern Europe, managing IVDR applications with BSI. Charlotte has solid knowledge of the IVD industry and understands the complexity of the IVDR applications. Whether you’re starting the certification process, looking to transfer or just need to discuss options for your business, Charlotte can guide you efficiently through the process.
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ABOUT LUNCH & LEARN
KI Science Park Lunch & Learn is an event that blend education and networking opportunities. Industry experts share their knowledge and expertise with our community, and anyone interested in the featured topic. Attendees will enjoy a light lunch as part of the experience. Join us for an enriching session that nourishes both the mind and connections within our vibrant community!
Welcome!
