Fang Consulting

Fang Consulting provides Regulatory Affairs, Clinical Affairs, and Quality Assurance activities for Medical Device companies and 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. Fang excels in providing combinations of Principal, Senior and Junior Consultants. Areas of Expertise and Service include but are not limited to: ? EU MDR Impact Assessment ? EU MDR Quality System Gap Assessment ? Design Document Gap Assessment ? Gap Response Plan ? Clinical Evaluation Reports ? Mock Audit ? EU MDR ? Notified Body Submission / Response ? Post ? Market Surveillance Services ? On-Site MDR Training