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ISO 13485:2016 Documentation Kit

₹65,000

Compliance with ISO 13485:2016, the medical device quality management standard, requires meticulous documentation to validate product safety and quality process efficacy. Our documentation strictly adheres to ISO 13485:2016 guidelines and regulatory mandates, ensuring comprehensive alignment with industry standards and legal obligations.

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Compliance with ISO 13485:2016, the standard for medical device quality management, demands thorough documentation to substantiate the safety of products and the efficacy of quality processes. This documentation adheres strictly to the standard’s guidelines as well as all relevant regulatory mandates, ensuring comprehensive alignment with industry standards and legal obligations.

  • QMS-MD MANUAL
  • DEPARTMENTAL PROCEDURES
  • QMS-MD PROCEDURES
  • SOPs
  • DEPARTMENTAL FORMATS AND SAMPLES
  • AUDIT LIST
  • QMS-MD POLICY
  • QMS-MD OBJECTIVES
  • SAMPLE LABELS
  • WORK INSTRUCTIONS

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