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FDAmedix

Medical Device Consulting, Auditing, Training
  • Medical Device RA/QA Services
    • EU MDR Compliance (2017/745)
    • ISO 13485 Certification Consulting
    • FDA 21 CFR 820 Implementation
    • QMS Compliance for Medical Software
    • Computer Software Validation (CSV) / Assurance (CSA)
    • MDSAP Internal Audits
    • FDA Mock Audits
    • FDA 483 Mitigation
    • CAPA & Root Cause Analysis
    • Critical Supplier Audits
    • Risk Management
    • GxMP GAMP
    • FDA 21 CFR Part 11 Compliance
    • Remote Medical Device Audits
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    • Medical Device QMS Auditing
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FDAmedix

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  • Medical Device RA/QA Services
    • EU MDR Compliance (2017/745)
    • ISO 13485 Certification Consulting
    • FDA 21 CFR 820 Implementation
    • QMS Compliance for Medical Software
    • Computer Software Validation (CSV) / Assurance (CSA)
    • MDSAP Internal Audits
    • FDA Mock Audits
    • FDA 483 Mitigation
    • CAPA & Root Cause Analysis
    • Critical Supplier Audits
    • Risk Management
    • GxMP GAMP
    • FDA 21 CFR Part 11 Compliance
    • Remote Medical Device Audits
    • Auditor Training
    • Medical Device QMS Auditing
    • Remediation Service
    • Cybersecurity
  • Contact Us
  • Request Quote
  • Resources
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  • Medical Device RA/QA Services
    • EU MDR Compliance (2017/745)
    • ISO 13485 Certification Consulting
    • FDA 21 CFR 820 Implementation
    • QMS Compliance for Medical Software
    • Computer Software Validation (CSV) / Assurance (CSA)
    • MDSAP Internal Audits
    • FDA Mock Audits
    • FDA 483 Mitigation
    • CAPA & Root Cause Analysis
    • Critical Supplier Audits
    • Risk Management
    • GxMP GAMP
    • FDA 21 CFR Part 11 Compliance
    • Remote Medical Device Audits
    • Auditor Training
    • Medical Device QMS Auditing
    • Remediation Service
    • Cybersecurity
  • Contact Us
  • Request Quote
  • Resources

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