ISO 13485: 2016

Quality Management System for Medical Devices

Quality Assurance in Medical Devices

The medical device industry is governed by complex regulatory systems. Compliance with national and international standards and other requirements is mandatory. Manufacturers of medical devices are responsible for consistently delivering devices that are safe and effective. Certification is needed before entering new markets or prior to customer order placements.


What is ISO 13485?

ISO 13485 defines the requirements for a comprehensive quality management system for the design and manufacture of medical devices. It ensures the consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose. An ISO 13485 certification enables an organization to do business in this highly regulated sector. ISO 13485 is relevant to all manufacturers of medical devices inclusive of subcontract manufacturers.



Compliance with regulatory and customer requirements, product safety, greater market opportunities, improves your company’s credibility, image and performance.


What are the key benefits of ISO 13485:2016?

  • The promotion and awareness of regulatory requirements as a management responsibility
  • Implementation of controls to ensure product safety
  • Risk management and design control during product development
  • Inspection and traceability for implantable devices
  • Documentation and validation of processes for sterile medical devices
  • Verification of the effectiveness of corrective and preventive actions
  • Improves customer satisfaction
  • Compliance to basic quality system requirements with enhancements
  • Risk management approach to product development and product realization
  • Validation of processes
  • Tracking and record keeping
  • Certification to this standard enables global trade
  • Regular assessments help monitor and improve management system and processes
  • Increases financial performance


Certification to ISO 13485 is often a mandatory requirement in the highly regulated medical devices industry. This certification demonstrates quality commitment to regulators and customers regardless of whether organizations engage in global operations or expand locally for new business ventures. The regular assessment process ensures that processes are continually checked for effectiveness and avoids noncompliance issues with regulatory bodies ensuring product safety.