REGULATORY AFFAIRS

To avoid the risk of delays in the market launch in the respective target market, ERGOSURG also carries the approval documents (CE, FDA, etc.) for complex products parallel to development. For more than 15 years we have been developing database systems to minimize the risk of a documentation gap. We know the requirements for the respective target markets and can support you in the following steps:

  • Preparation of the necessary approval documents
  • Preparation and fulfilment of test protocols
  • Handling of harmonized audits, for example on EMC, UL, NRTL, with the corresponding partners
  • Cooperation with Notified Bodies
  • Preparation and partner search for clinical trials