Faster from idea to market!
Work together to drive innovation and mitigate risk.
Over the past 10 years, more than 1,200 medical technology startups have strengthened Germany’s position as a hub for innovation. Despite strong support from startup hubs, MedTech startups in particular face unique challenges:
- Enormous regulatory effort
- Very specific user requirements
- Difficulties in financing & finding investors
- Long development times & high costs
Fast solutions for complex technical requirements and regulatory hurdles.
As experts in monitoring, defibrillation & critical care, we support you with:
- Class IIb & III devices & software
- Specific and technically complex specifications
- Solutions at all stages of development
- Cybersecurity, functional safety
- Reviews for algorithms, hardware, layout
- Regulatory challenges
- Approval, manufacturing & lifecycle management
Our startup kits answer your most important questions:
- I have an idea, but I don’t know how best to implement it – how much effort is involved?
- I have my prototype and want to prepare for approval – how do I test and verify it?
- I have a good product and need quick help with regulatory approval – how can I review my processes for MDR?
- I have completed the development of my medical device – how do I get it into production quickly and cost effectively?
System Footprint Workshop
Is your medical device start-up ready for the market? The System Footprint Workshop helps you optimize your product from the ground up and expedite your time to market. In this intensive workshop, we work with you to analyze the entire system landscape of your product, from hardware to software, and identify potential regulatory challenges and technical improvement opportunities.
Test & Verification
Is your medical device safe and reliable? This Test & Verify session will help you ensure the quality of your product and meet regulatory requirements. We will work with you to develop a comprehensive test plan that covers all relevant aspects of your product – from function to safety – and produce the necessary documentation for your approval.
Conformity check
Does your medical device comply with relevant standards and regulations? The Conformity Check Workshop helps you to check the conformity of your product and to ensure that it meets the requirements for approval – for software safety, FMEA and the entire development process. We work with you to analyze the standards and regulations that apply to your product. We identify potential compliance gaps and develop a plan to close them.
Design Transfer & LCM
Is your MedTech product ready for mass production? The Design Transfer & LCM Workshop helps you smoothly transfer your product from design to production and establish an efficient life cycle management process. We guide you through all phases of design transfer, mass production and LCM to ensure that your medical device is efficiently and cost-effectively manufactured and optimally managed throughout its lifecycle.
Start directly with the free initial consultation!
Dorothee Ogiermann-Kitz
Business Development Manager
