Malinda Scherf's Company Details
Roseville, MN, US • 20 - 49 Employees
Medical Equipment
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)