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  • Medtech consulting
    • PRRC
    • QA&RA manager for hire
    • Small Business Solutions
    • MDR transfer process
    • IVDR transfer process
    • Due diligence
  • Medical Devices – Prestudy
    • Requirements analysis
    • Regulatory strategy
  • Medical Devices – Clinical evidence
    • Clinical Evidence
    • Clinical evaluation / Clinical investigation
    • Performance evaluation (IVD)
    • Summary of Safety and Clinical Performance (SSCP)
    • Summary of Safety and Performance (SSP)
  • Medical Devices – Development
    • Risk management
    • Software risk management
    • Software validation
    • Software Quality Assurance
    • Quality management systems
    • Unique device identification
    • Product verification and validation
    • Computer systems validation
    • Technical documentation for CE marking
      • GSPR
  • Medical Devices – Manufacturing
    • Process validation
    • Computer systems validation
  • Medical Devices – Market access
    • EU
    • European Authorized Representative
    • UK Responsible Person
    • USA
    • Canada
    • Japan
    • China
    • Other countries
  • Regulatory – Post-market
    • Internal audits
    • Supplier audits
    • FDA inspections
    • Notified body audits
    • Post market surveillance (PMS)
    • Regulatory surveillance
  • The 7th EAAR Annual Conference on the New Medical Device RegulationsJanuary 17, 2023 - 1:13 pm
  • This Christmas we save children’s livesDecember 19, 2022 - 3:44 pm
  • Proposed changes of MDR transition timesDecember 14, 2022 - 12:23 pm

 

 

We are longtime trusted providers of MedTech quality and system management, risk management, compliance, training, interim management and regulatory affairs. Offering a thorough knowledge and understanding of the industry, based on 30 years of professional experience, QAdvis have the tools to help take your MedTech innovations to domestic and international markets.

Contact Us

Lund office +46 46 286 88 90
Stockholm office +46 8 621 01 05
QAdvis UK +44 808 234 4051
QAdvis EAR +46 8 621 01 05

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