Regulatory Compliance

 

European CE Marking,

Technical Files,

US FDA 510(k) Clearance,

US PMA Approvals

Canadian Medical Device License

Canadian/US FDA Establishment License

Quality System Compliance

 

US FDA GMP And Quality System Regulation

ISO 13485 Consulting (With/Without CMDCAS)

Canadian Medical Device Requirements (CMDCAS)

FDA 483 Response,

Internal And Supplier QMS Audits,

QA/QMS Compliance Services

Other Services

 

Corporate/employee Training

Medical Device Validation Consulting (including software)

ISO 14971 Consultants for Medical Device Risk Management

Call us or email us your questions. We'll get back with a free estimate.