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Management systems for medical devices

The international standard ISO 13485 defines requirements for a quality management system for medical devices when an organization needs to demonstrate its ability to provide medical devices and related services in a timely and high-quality manner, which in turn must regularly meet regulatory and customer requirements.

The benefits of certification for your organization:

  • International recognition of ISO 13485 compliance when undergoing certification
  • Improvement of regulatory and contractual requirements
  • Assistance in monitoring supply chain performance
  • Increased revenue
  • Improved product safety
  • Improved manufacturing efficiencies
  • Prevention, detection and avoidance of errors related to production
  • Cost savings
  • Better risk management
  • Increased customer (consumer) satisfaction

Benefits of certification for your customers (consumers):

  • Confirmation of compliance with the quality management system of medical devices produced
  • Ensuring the safety of medical devices for the client (consumer)
  • Increasing the confidence and trust of the client (consumer) in the services of your company, etc.

Certificate issuance and renewal

ISO 13485 certification is an independent verification conducted by Central Asia Certification, which verifies the organization’s compliance with ISO 13485.

Upon successful completion of the certification, the organization is issued a certificate. The certificate is then maintained through regular annual surveillance inspections over a period of time:

  • 3 years – when obtaining an international certificate

After the expiry of the certificate, recertification (recertification) of the quality management system of medical devices is carried out (at the request of the customer).

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