Fang Consulting handles the Regulatory Affairs and Quality activities for Medical Device manufacturers. We specialize in US and OUS submissions for Class II and III medical devices. We also set up and manage CFR 820 and ISO 13485 compliant Quality Systems.

Regulatory Affairs Quality Systems Clinical Affairs MDR ISO 13485 PMA CE Mark 510(k) Class I II III Medical Devices HIPAA Compliant 21 CFR Clinical Study Monitoring Clinical Trial Monitoring Quality Engineering Verification and Validation Medical Device Fulfillment Statistics Technical File Preparation Design Dossier Preparation Virtual Company QMS Management Web-Based QMS Management UDI Labelling Clinical Evaluation Report (CER)