Services Provided

Managing Quality Systems

ISO 13485, 21 CFR 820, and MDSAP

Management Review

Training Management​

FDA Inspection Support

Notified Body Audit Support

Supplier Management

Document and Record Control

Regulatory Compliance

State Licensing

International Registrations

UDI and Labeling

Advertisement & Promotional Materials

FDA device listing & Establishment Registration, Health Canada Licensing

Notified Body Interactions

Technical Documentation

Quality Engineering Support

Process Validations

Risk Management

Design Control Support

Complaint Investigations

CAPA and Field Actions