PORTFOLIO

Compilation of technical documentation for MDR and other markets

Person Responsible for Regulatory Compliance (PRRC) according to MDR Article 15

Authorized Representative in the EU (EC REP) according to MDR Article 11

Internal auditor for ISO 13485 and MDSAP

Global regulatory strategy for medical devices

Training and education around regulatory affairs for medical devices

Do you need other support? Please feel free to contact me. Together we will find out which cooperation opportunities exist.