Full List Of Services​

Full list of services

Our services include:

  • Developing a regulatory strategy depending on the product and desired market, including classification of device
  • Regulatory Due Diligence for projects and prospective acquisitions
  • Expertise in Biocompatibility Risk Assessment – EN ISO 10993-1:2018
  • Developing and implementing Risk Management programs – EN ISO 14971:2019
  • Device History File (DHF) and design control 
Our Team Of Experts Is Qualified To Guide You Through Full Registration In Various Global Markets, Including Set-Up Of Technical Documentation:
  • Set up of DHF, DMR and other records and reports:
  • Design Input file preparation
  • User Needs Document
  • Design and Development Plan
  • System Level Requirements
  • Hazard and Background Checklist
  • Assistance with material’s biocompatibility assessment
  • Biocompatibility Risk Assessment – EN ISO 10993-1:2018
  • Project Plan preparation and Project Management throughout the project’s lifecycle, as required per ISO 14971:2019, including:
  • FMEA
  • Risk Management plan
  • Risk analysis
  • Manufacturing Plan Development
  • Quality Systems evaluations & gap-analysis
  • Technical feasibility studies
  • Developing and implementing QMS plans & strategies:
  • SOP development/reviews
  • MDSAP Audits compliance (for FDA, Canada, Japan, Australia, Brazil)
  • Forms development
  • Assistance with Sterilization Validations
  • ISO 13485 compliance & certification
  • RISK Based approach
  • Closed-Loop Traceability(CLT)
  • CAPA System Management
  • Change Control Management
  • MRB handling
  • Complaints handling

GMRE

Global Medical Regulation Experts

GMRE was created to guide and support MedTech startups and established companies in introducing and keeping their medical products in the global market in the most efficient way.
Israel HQ
Canada/US HQ

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Discover the medical regulatory startegy that will achieve the most effective results

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