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ISO 13485 : 2016 Certification

ISO 13485 is a quality management system specifically designed for medical device manufactures, designers and developers which is similar to US FDA 21 CFR 820. Implementation of ISO 13485 helps an organization to keep the quality and consistency of medical devices, moreover it is an assurance to their clients about the quality of their product. ISO 13485 is a mandatory requirement for CE Marking which is the key to enter in to the European medical device market.

LMG provide complete assistance in ISO 13485 implementation which includes,

  • Documentation - Quality Manual and Procedures
  • Evidences - Generating Records
  • Training - Awareness about ISO 13485 among team members
  • Internal Quality Audit - Planned audit between team members
  • Third Party Audit - Planned audit by Certification Body team of auditors
  • Maintenance - Maintain ISO 13485 system throughout the year and thereafter

Cost for ISO 13485 : 2016 Certification

The Cost for ISO 13485 : 2016 certification vary from organization to organization, it depends on various factors like -

  • Scope of ISO 13485
  • Number of devices
  • Manufacturing process
  • Number of employees
  • Manufacturing shop floor area
  • Notified body / registrar / certifying body selected

If interested, Please contact us with detailed information for an approximate budgetary quote.