Medical Device Services that we can assist your firm with include:
510k Submission, Preparation and Response
Sterile Product Verification and Validation
CAPA- Corrective and Preventive Actions
Design History Files, Device Master Records – Document Control Service, Technical Writing, Labeling and Packaging
Hazard Analysis, Risk Mitigation and Failure Mode Effects and Analysis
ISO 13485, GMP and Quality Systems Regulations
Standards Testing, Electrical and Safety, Sterility