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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 18, 2024:

4C Close up – Insights into C1 | Selective contracts as a business model, underestimated or overrated?

Selective contracts can open the door to the healthcare market. However, young companies face a number of challenges: from contacting health insurance companies, to requirements of regulations, like §140a SGB V, and authorities, such as the Bundesamt für Soziale Sicherung, to the actual contract negotiations.

Join us for our next 4C Close-up webinar with Jürgen Stein from mentalis GmbH. He will give you practical insights into the process leading up to a signed selective contract with a health insurance company. Together with startup coach Ingo Hämmerle, he will discuss the differences between insurance companies, what they expect from a startup and which regulations and authorities are particularly challenging along the way.

  • What? Insights into C1 | Selective contracts as a business model, underestimated or overrated? 
  • Who? Jürgen Stein (mentalis GmbH) & Ingo Hämmerle (MII)
  • When? April, 18, 2024, 5-6 pm CET
  • How? Register here for the free webinar!

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.

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 | 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.

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.