WHAT IS IT ABOUT?
C1 | Commercialization: How do I generate revenuein the healthcare sector?
C2 |Certification: How does the certification of my product and my company work?
C3 |Clinical Studies: How do I prove safety and performance of my product?
C4 |Copyright: How can I use dataand property rights for my own advantage?
WHAT IS THE GOAL?
- You will have identified corresponding barriers to shorten the time-to-market and considered them in an individual project plan.
- You will be familiar with the reimbursement options in the healthcare market(e.g., self-payer, AMNOG or selective contracts).
- You will know how quality management systems (e.g.,ISO 13485, Good manufacturing practice (GMP)) and regulatory processes become a strategic concept and how they effectively lead to approval of your product (e.g.,Medical Device Regulation, In-Vitro-Diagnostic Regulation, Medicinal Products Act).
- You will be able to assess whether and what kind of clinical studies you need and how to best implement them(e.g., ISO 14155, ICH Guidelines).
- You will know how to deal with data protection requirements (DSGVO) and how to strategically protect and exploit intellectual propertyrights(e.g., patent).
More information can be found ont he official website of the program: https://mi-incubator.com/en/startup-services/