Regulatory Affairs

Demonstrating the value of a product: With our expertise leading the way to market launch

Many individual steps are required for the approval of medical devices, each dependent on the product objective and market. As your partner with a high level of expertise and
consulting competences, we support you in all necessary approval processes and audits.

We provide:

• Quality management consulting for the requirements of ISO 9001 and EN and/or ISO 13485 standards
• Consulting and preparation for certification according to the Medical Device Act MPG, the Medical Device Regulation MDR (EU) 2017/745 and the Medical Device Operator Ordinance (MPBetriebV), process definition and documentation, product design domination
• Technical documentation
• Internal auditing
• Consulting for clinical trials on medical devices
• Consulting and preparation for external auditing, authorities and notified bodies
• Consulting and preparation for the approval of medical devices (CE, type – as well as preparation for the type examination certificate)
• Expert opinions and certificate testing (marketability testing of imported goods, labeling and labeling of medical devices, traceability)

We love to Deep Dive into all legal frameworks!