Operon Strategist is a medical device consultant provide service to medical industries in 100+ countries all around the world. The 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