Obtaining approval for a medical device is the key to market access for regulated countries. The requirements differ by the regulatory framework set by the authority. I can support you in the application process by:

• Identifying the specific requirements

• Compiling the application files including the technical documentation

• Communicating with authorities, Notified Bodies and local representatives

The fulfillment of the quality management system (QMS) is an integral part of medical device manufacturers. As certified lead auditor for ISO 13485 and MDSAP I offer support in the field of QMS:

• Internal audits

• Set up of Standard Operation Procedures (SOP)

• Audit support for the fulfillment of ISO 13485, MDSAP, MHLW MO No. 169 (Japan) and KGMP (Korea)

Since 2024 I have been conducting training in the area of regulatory affairs of medical devices. A strong focus here are the regulatory landscapes of

• Japan

• South Korea

• Taiwan

• Singapore / ASEAN

Non-EU manufacturers need to appoint an authorized representative (EC REP) for the import and distribution of their medical devices in the EU according to MDR Article 11.

 

Medical device manufacturers need to have a Person Responsible for Regulatory Compliance (PRRC) according to MDR Article 15.

 

GRSHC offers both functions.