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4C Accelerator – Medical Innovations Incubator
19. July 2024
Your added value through training in the 4Cs & Regulatory Thinking®
C1 | Commercialization
You will gain knowledge of the reimbursement opportunities in the healthcare market and know how to leverage them and map them in your business plan (e.g. self-payers, reimbursement options of the health insurances, like selective contracts and DiGA). You will also identify topics from C2 to C4 that will be relevant for marketing your product – the interlinking of the 4Cs begins.
You will gain knowledge of the reimbursement opportunities in the healthcare market and know how to leverage them and map them in your business plan (e.g. self-payers, reimbursement options of the health insurances, like selective contracts and DiGA). You will also identify topics from C2 to C4 that will be relevant for marketing your product – the interlinking of the 4Cs begins.
C2 | Certification
You will be enabled to set up a quality management system (QMS) according to ISO 13485 and its processes and to set up the technical documentation according to the Medical Device Regulation (MDR) or the In Vitro Diagnostic Regulation (IVDR) to obtain the medical CE marking of your product – key steps for market access taking into account your claims.
You will be enabled to set up a quality management system (QMS) according to ISO 13485 and its processes and to set up the technical documentation according to the Medical Device Regulation (MDR) or the In Vitro Diagnostic Regulation (IVDR) to obtain the medical CE marking of your product – key steps for market access taking into account your claims.
C3 | Clinical Studies
We provide transparency on the process of clinical evaluation, on the different objectives and designs of clinical studies and convey knowledge for their concrete implementation (e.g., ISO 14155 / ISO 13612). Always keeping in mind: the certification of your product (C2) on the one hand and your commercialization strategy (C1) on the other.
We provide transparency on the process of clinical evaluation, on the different objectives and designs of clinical studies and convey knowledge for their concrete implementation (e.g., ISO 14155 / ISO 13612). Always keeping in mind: the certification of your product (C2) on the one hand and your commercialization strategy (C1) on the other.
C4 | Copyright
We provide knowledge about the possibilities to protect your innovation (e.g., patents) – including software components – as well as about the requirements of data protection (DSGVO) in the healthcare sector.
We provide knowledge about the possibilities to protect your innovation (e.g., patents) – including software components – as well as about the requirements of data protection (DSGVO) in the healthcare sector.
Regulatory Thinking®
By training the Regulatoy Thinking® method as a mindset, you will learn to understand the regulatory requirements in the topics of the 4Cs in an interconnected way and to integrate them holistically into your business model. This will enable you to create a well thought-out roadmap, to calculate and negotiate realistic investment volumes and to develop a regulatory plausible and entrepreneurially successful business model.
By training the Regulatoy Thinking® method as a mindset, you will learn to understand the regulatory requirements in the topics of the 4Cs in an interconnected way and to integrate them holistically into your business model. This will enable you to create a well thought-out roadmap, to calculate and negotiate realistic investment volumes and to develop a regulatory plausible and entrepreneurially successful business model.
What awaits you
- Experience from supporting over 120 startups
- Experience from various coaching and consulting projects
- Industry-specific approach: 4C & Regulatory Thinking®
- Professional specialization of the MII coaches
- High-quality and industry-specific network
Contact
Lea Renz
Email: renz@mi-incubator.com
Phone: +49 152 52998535