Fang Consulting handles the Regulatory Affairs, Clinical 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.
At Fang Consulting, you have the ability to source the team that fits your needs. Fang excels in providing combinations of Sr. Level and Jr. Level team members. Let us manage your project, help control your costs and ensure your success.
Areas of Service:
MDR Impact Assessment
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