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Webinar Series: 4C Close-up – Insights into …

Have you ever wondered what a clinical evaluation of a medical device looks like? Or what its scope with regard to its corresponding documents is? We provide remedy!

In our webinar series “4C Close-up”, our internal MII-experts discuss practical topics focusing on one of the 4Cs with experienced practitioners from advanced startups or established companies. We provide you with close-up insights into real world examples (e.g., regulatory documents). Always with our goal in mind: Enabling you to help yourself!

July 30, 2024:

4C Close-up | Insights into C2 – How to successfully certify a large language model as a medical device

AI technologies such as Large Language Model (LLM) are the future – also in the healthcare sector. But while the technology is developing rapidly, regulation is lagging behind. The certification of AI-based medical devices and IVDs therefore poses new challenges for both young and established companies. Because how can you ensure the consistent safety and performance of a product that is potentially constantly changing?

Join us for our next 4C Close-up Webinar with Dr. Vera Rödel, CEO and Co-Founder of Prof. Valmed® – validated medical information GmbH. She will share her experiences around the certification process of her LLM medical product. Together with MII expert Dr. Henrike Stutzki, Vera will address the topics of validation, clinical evaluation and certification process and share her most important learnings.

  • What? Insights into C2 – How to successfully certify a large language model as a medical device
  • Who? Dr. Vera Rödel (Prof. Valmed®) & Dr. Henrike Stutzki (MII)
  • When? July, 30, 2024, 12.30-1.30 pm CEST
  • How? Register here for the free webinar!

Previous 4C Close-up webinars

Insights into C1 | Selective contracts as a business model, underestimated or overrated?

Jürgen Stein, CEO at mentalis GmbH, shared his first-hand experience with selective contracts and the challenges and opportunities they present. Together with Ingo Hämmerle, he discussed, what insurance companies expect from a startup and what one can expect from them in return.

Insights into C3 | Reimbursement achieved – now how to get into sales?

Janina Clasen, QARA Manager of Skinuvita, shared experiences in planning, approval and coordination from the startup’s multi-center clinical trial to prove the safety and performance of their innovative medical device.

Insights into C2 | Reimbursement achieved – now how to get into sales?

Matthias Schurig, sales and marketing expert at Oviva, gave insights into the marketing strategy of their DiGA-listed medical device and showed with practical examples how they made it from a handful to several thousand sales.

4C CLose-up Webinar - Requirements engineering
Insights into C2 | Requirements engineering & good product development

Co-Founder and QARA responsible Stefan Hotz from the startup Kamedi addressed the topic of requirements engineering and provided insights into how his team derived, captured and implemented the requirements for their medical device heat_it® during the design and development process to achieve a MDR-compliant technical documentation.

Insights into C2 | How to just do QMS

Our guests Dr. Ramona Samba (CEO) and Niko Mangold (RA) from the startup sync2brain provided exclusive insights into their ISO 13485 certified QMS, its structure, scope and individual SOPs. Together with our MII startup coach Henrike, they discussed how to build your own QMS as a startup so that it meets regulatory requirements and is livable in everyday life.

Insights into C3 | Clinical Evaluation Process

Our first 4C Close-up Webinar provided insights into C3 and the Clinical Evaluation process. Our guest Dr. Ruth Schippert from Okuvision GmbH, together with our MII expert for Clinical Affairs, Henrike, gave insights into the documents of the Clinical Evaluation Plan and Report as well as into the processes of literature search and evaluation.