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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!
April 25, 2023:
4C Close up – Insights into C2 | Requirements engineering & good product development
Join our next 4C Close-up Webinar and learn how the team from Kamedi GmbH approached the topic of requirements engineering. Co-Founder and QARA responsible Stefan Hotz will provide insights on who they derived, captured and implemented the product requirements for their medical device heat_it® during the design and development process in order to achieve a MDR compliant technical documentation. He and MII startup coach Dr. Henrike Stutzki will also talk about how to deal with new requirements in the context of change management. Parallels for in vitro diagnostics in terms of the IVDR will also be highlighted in this webinar.
- What? Insights into C2 | Requirements engineering & good product development
- Who? Stefan Hotz (Kamedi GmbH), & Dr. Henrike Stutzki (MII)
- When? April 25, 5-6 pm CET
- How? Register here for the free online webinar!
Previous 4C Close-up webinars
Recap: 4C Close-up - Insights into C3 | Clinical Evaluation Process, July 27, 2022
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.
Recap: 4C Close-up - Insights into C2 | How to just do QMS, Dez 5, 2022
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.