ISO 13485 Medical Devices

ISO 13485 Medical Devices

QI : is a quality standard specifically for Medical

Device and related services that consistently meet customer and applicable regulatory requirements

Adopting this standard is beneficial to the organization in many ways:-

  1. Promotes harmonization of regulatory requirements for the manufacturers of medical devices on an international scale.
  2. ISO 13485 is a quality system standard for organizations that design, develop, produce or service medical devices. All requirements of ISO 13485 are specific to organizations manufacturing medical devices, regardless of the type or size of the organization.
  3. Companies that achieve ISO 13485 certification enjoy the benefits of an increased amount of customers who have more reason to trust and purchase products of consistent high quality.
  4. ISO 13485 will benefit customers, suppliers, management, and especially workers
  5. Rapid and effective communication, feedback, and recognition on efforts made, results achieved, and work to be done
  6. Continuous assessment, improvement, and re-registration of systems.
  7. ISO 13485 certification is advantageous to medical device companies which export their products to global markets. Some of the additional requirements relate to design controls, process controls (including environmental controls), special processes, traceability, record retention, and regulatory actions, which are more critical for the medical device industry.
  8. ISO 13485 compliant management systems adopt a risk management approach, which includes assessment to identify & estimate risk, uses risk controls and techniques with a view to eliminate hazardous situations throughout product realization.
  9. Assures the customers that the product complies with all relevant product & service-oriented technical standards & regulations.

Emphasizes the cleanliness & sterility in the production area, which in turn increases efficiency & enhances safety at the workplace.



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