Operon Strategist

Medical Device Regulatory Consulting organization provides regulatory guidance to medical device manufacturer as well as primary packaging material manufacturers. Our services include:
1. Facility Layout Design
2. Clean Room Design
3. Process validation
4. QMS and Certification like ISO 13485, ISO 15378, USFDA, CE marking, TGA, ANVISA, 21 CFR 820, 21 CFR 210, 21 CFR 211, etc.
5. Design and development for the combination product
6. Post-marketing support