FastTrack MedTech

FastTrack MedTech GmbH is an industry-in-clinic platform based in Erlangen, Germany, funded by the German Federal Ministry of Research, Technology and Space and connected to the Medical Valley EMN cluster. It brings product developers into the clinic early, giving medtech companies access to clinical expertise, realistic test environments and clinical investigations, and supports them through regulatory approval and market access. Alongside planning and conducting clinical investigations for medical device companies, FastTrack runs user research such as surveys and in-depth interviews so products match what clinicians and patients need.

FastTrack MedTech is currently in the certification process for ISO 9001 and works with sponsors on a flexible, project-by-project basis.

At a glance

• Partner type

  Clinical research organisation and industry-in-clinic platform
• Headquarters

  Erlangen, Germany
• Regions

  Germany and DACH
• Typical clients

  Medtech start-ups and SMEs; health innovators
• Trial types

  Medical device clinical investigations (ISO 14155, MDR Articles 62 and 82), feasibility studies, observational studies, PMCF
• In-house services

  Project management, clinical monitoring, site selection and clinic access, user research, regulatory guidance, market access and funding advice
• Regulatory experience

  EU MDR, EU CTR
• Quality system

  ISO 9001 certification in progress
• Pricing model

  Flexible, depends on the project

Find out more

Visit fasttrackmedtech.de. To be introduced through Ledidi, get in touch. Interested in joining the partner ecosystem? Become a partner.