Quality by Design
December 6, 2022
ISO13485 is an internationally developed and published standard, also adopted in South Africa as a national standard, as the framework for the development, implementation and maintenance of the organization’s quality management system to assure relevant parties, which includes users, customers, regulators of the safety and performance of medical devices and IVDs, and provides confidence that medical devices are designed, produced, supplied and marketed following established general safety and performance principles; as well as meeting regulatory compliance.
This may appear to be a tedious, onerous and costly task however if done with committed and participative leadership the rewards, besides retaining an establishment license with SAHPRA, will outweigh the perceived disadvantages.
