Considering the continuous technical innovation, regulatory requirements of various countries should not be a handicap.

As experienced and certified manager Regulatory Affairs for medical products and in-vitro diagnostics as well as active implantable medical products we habe effective strategies and mechanisms for an efficient market access for your products.

We accompany you from the engineering to the admission as medical products. Also we support you in the product maintenance:

• methodical monitoring durin the engineering  e.g.  EN ISO 13485:2016  and 21 CFR 820.30 (Design controls)
• evaluation and implementation of Design Reviews
• establishment and maintenance als well as redevelopment of technical data e.g. Design History File (DHF), Devic Master Record (DMR), Summary Technical Documentation (STED)
• international approvals (e.g. USA, South America, China)
• operational support for the communication with the national authorities of your target markets
• Operative Unterstützung zur Kommunikation mit benannten Stellen und nationalen Behörden ihrer Zielmärkte.

Please convince yourself of our expertise: medizintechnik@andreasstrauss.de.

We are looking forward to your inquiry.