Medical Innovations Incubator
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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!
Previous 4C Close-up webinars
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.
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 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.