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

sERVICES

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