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4. Konsultasi ISO 13485:2016

4. Konsultasi ISO 13485:2016


Consultation ISO 13485:2016

ISO 13485: 2016 is an international standard issued in 2016 as a requirement for a comprehensive MANAGEMENT DESIGN AND MANUFACTURE OF MEDICAL DEVICES. The main objective of this standard is to facilitate quality management system requirements that are in line with regulatory objectives in the medical device sector.

ISO 13485: 2016 establishes requirements for a quality management system where organizations are required to provide medical devices and related services that consistently meet customer and regulatory requirements. Organizations may be involved in one or more life cycle stages, including the design and development, production, storage and distribution, installation, repair of medical devices or development of related activities. ISO 13485: 2016 can also be used by external parties who provide products, including services related to quality management systems to organizations.


Benefits of ISO 13485:2016

  1. Ensure compliance with standard and other requirements.
  2. Trimming the process of increasing efficiency so as to result in significant time and cost savings.
  3. Gain a competitive advantage with an independent and  globally recognized third-   party certification.
  4. Is a source for all your testing and certification needs.
  5. Provide experience, expertise, and international competition in the medical equipment market.
  6. Facilitating planning, controlling, monitoring, preventing and improving, auditing and reviewing activities to ensure that the policy is adhered to and that the management system remains appropriate.
  7. Able to adapt to changing circumstance

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