Contract US and Offshore Medical Device Development
Turnkey EU MDR Remediation
” “After May 2020, non-compliant companies will likely lose their CE mark certification as well as access to the European market. Non-compliant Notified Bodies, similarly, may lose re-designation.
– The FDA Group “Complete Guide to EU-MDR Transition
eXAMPLE PRODUCT DEVELOPMENT
Most device companies have started this process. Is your company on schedule?
Outsource DHF Remediation
Global Device Solutions has designed and verified medical devices since 2003. Let us help.
We work locally; even in your office. We also can manage the offshoring of documentation to Asia to make our hourly rates lowest in industry!
offshore to minnesota???
OUR REMEDIATION PROCESS
We will review your Legacy Design History Files to ensure conformance with EU MDR “State of The Art” documentation requirements
LABELS AND INSTRUCTIONS FOR USE
COMPLAINT HISTORY REVIEW
RISK MANAGEMENT (ISO 14971-2012)
DESIGN VERIFICATION/validation TESTING
Products designed 20+ years ago? No problem. Let us help create:
- Write test methods
- Test method validation
- Accelerated and real time aging
- Protocols & reports
- Perform DV testing
- Human Factors Evaluation
EU MDR DESIGN HISTORY FILE REMEDIATION
New design or fix old legacy files; it’s what we do