Medical Innovations Incubator
Home of 4C - Enabling Life Science Innovations
4C Services
Our startup-friendly services are targeted at MedTech startups with medical devices, in vitro diagnostics or digital health applications and are based on our approach of 4C concept and Regulatory Thinking® methode. By that, we have the ability to take a linked view of the regulatory requirements of the 4C topics and the associated challenges and opportunities, and to have a holistic view on your business model.
We provide you with strategic and implementation support for all 4C challenges that await you as a MedTech startup: from QMS, Technical Documentation and clinical studies to matters of reimbursement by health insurance companies and discussions with investors.
Our 4C Deep Dive Services
We ENABLE you!
We empower you through individual consulting, seminars, workshops, pre-filled templates incl. methodical guidance or the combination of different formats. In doing so, we always consider the relevant regulatory aspects as well as your individual level of experience. Our goal is to enable you to continue to work with the results independently.
Depending on the topic and individual requirements, the services are carried out by our interdisciplinary team or together with highly qualified partner companies.
We REVIEWE your documents!
Together with regulatory experts, e.g. from the certification body QS Schaffhausen AG, we support you with pre-assessments and internal audits. We check your documents, and you receive a written report. If required, we can prepare the results in a joint workshop.
This is the ideal preparation for the submission of application documents, for an external audit or for other official document checks.
Enabling to …
- Stakeholder mapping
- Product/market fit analysis
- Market access strategies
- Reimbursement variants
- Preparation of reimbursement application
- Cash cycle/cashflow mapping
- Pricing strategy incl. validation
Review of …
- Business plan
- Sales strategies and distributor contracts
- Reimbursement applications
Enabling to …
- Basic understanding of Technical Documentation (TD)
- Definition of indented use
- Determination of risk class
- Requirements engineering
- Design and development plan
- Usability engineering according to IEC 62366
- Risk management according to ISO 14971
- QMS process landscape according to ISO 13485, GMP
Review of …
- TD according to MDR/IVDR, ISO 13485, GMP
- QMS according to MDR/IVDR, ISO 13485, GMP
Enabling to …
- Strategy on required pre-/clinical data for certification
- Flow of clinical evaluation/performance evaluation process according to MDR/IVDR
- Preparation of Clinical Evaluation Plan (CEP) and Clinical Evaluation Report (CER)
- CEP and CER templates
- Process of literature search and literature appraisal
- Conception and planning of a clinical study/performance study
- Definition of primary and secondary endpoints for a clinical study
- Application for approval of a clinical study to ethics committee and/or authority (BfArM)
- Preparation of study protocol and/or study report
Review of …
- CEP and CER according to MDR/IVDR
- Study protocol regarding selected endpoints and study design
- Study protocol according to MDR/IVDR, ISO 14155/ISO 13612
- Patient information and informed consent