International Regulatory Affairs
- CE Mark
- Health Canada
- Australia / New Zealand
- R.O.W. Registrations
- US Agent
- ISO 13485:2003 CAND/CAS
Are you frustrated trying to get answers for your international regulatory requirements? We can help!
Let us assist you with European CE Marking, Australian TGA and Canadian CMDR as well as R.O.W.(Rest Of World) product registrations.
We have implemented and upgraded ISO 13485:2003 quality systems for our medical products manufacturers. Additionally, we offer QA outsourcing as required to schedule and assist with audits.
We can help you obtain the CE Mark (CE Marking) for your medical devices as we have experience in providing support to compile Technical Files for a wide range of medical devices.