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Regulatory updates for the medical device industry

The most important changes to ISO 13485:2016

One of the important changes of the revision is that the new ISO 13485 uses a risk management approach in all processes of the quality management system.

Other major changes include:

  • Validation of the computer software used in the quality management system
  • Establishment and maintenance of the technical documentation structured to the clauses of the standard for the technical file and design and development files
  • New requirements for complaint-handling processes
  • Validation of processes for sterile barrier systems and sterilization
  • Definition of the required competence of personnel involved in quality management; documentation and verification of the effectiveness of training measures

For more information about the changes, see our ISO 13485:2016 factsheet, which is available for download here.

The necessary transition of your certificate is as follows:

  • Since the official publication of ISO 13485:2016 on March 1, 2016, the transition of accredited certifications to the new ISO 13485:2016 can now be effected within the scope of a regular surveillance or recertification audit. If the transition is carried out within the scope of a surveillance audit, additional audit time needs to be scheduled.
  • Manufacturers of medical devices and other organizations that hold an ISO 13485 certificate should therefore address the requirements of the new standard without delay, so that they can assess the extent of the changes that they need to implement in their existing quality management system and the time needed for said implementation.
ISO 13485: Our services

E-ssentials MedDev Team

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