Computer system validation services  21 CFR Part 11

21 CFR Part 11 Gap Assessment Audit

21CFR Part 11 QMS for Medical Devices
FDA Quality System Regulation
Medical Device 21 CFR 820
ISO 13485 Internal Audit
CGMP based QMS for Medical Devices
Medical Device ISO 13485 QMS

Our Specialization

CDAQi is committed to helping our clients to achieve regulatory compliance, world-class product reliability, and patient and user safety.
CDAQi provide solutions to eliminate human errors to meet patient safety in hospitals and highly regulated compliance organizations.
CDAQi provide System implementation, Regulatory documentation,Training and Audit services to help companies to become world class.
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Business Consulting Services

  • MDD 93/42/EEC CE Marking
  • QSR 21CFR 820
  • Risk Management 14971

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Audit Services

  • USFDA(21 CFR Part 820) Mock Audit
  • GMP Audit
  • 5S Audit
  • Vendor Management Audit
  • Supplier Audit

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Training Services

  • Regulatory Related Services
  • Modern Management Concepts
  • Medical Device Directives
  • GMP Training

 

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