cleanroom-moldingMedical 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