- Application of risk-based approaches in the 2016 standard now extend beyond product realization processes alone.;
- Increased linkage with regulatory requirements, particularly for regulatory documentation;
- Application to organizations throughout the lifecycle and supply chain for medical devices;
- Harmonization of the requirements for software validation for different software applications. In previous versions of ISO 13485, this has not been as clear as it needed to be. Software validation and on-going functional verification of software are now equally importance across the standard.
- Emphasis on appropriate infrastructure,particularly for production of sterile medical devices, and addition of requirements for validation of sterile barrier properties.
- Additional requirements in design and development on consideration of usability.
- Emphasis on complaint handling and reporting to regulatory authorities
- Planning and documenting corrective action and preventive action
- Greater supplier controls, including risk-based controls
- Additional management review requirements
- The integration of competency with training requirements
- Validation using pre-clinical and clinical evaluations
- Validation of packaging and distribution requirements
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