February 22, 2024
look no further contact www.isohealthsa.co.za +30years experience many successes with a get it done well approach A Quality Management System, or QMS, is essential for improving […]
March 2, 2023
A quality management system (QMS) can be defined as a collection of business processes that focus on meeting customer and regulatory requirements on a consistent basis. […]
December 19, 2022
Simone Rudolph-Shortt 19th Jan 2023 https://ec.europa.eu/commission/presscorner/detail/en/ip_23_23 Medical Device Class Transition Period Class III implantable custom-made devices May 26, 2026 Remaining class III devices Class IIb implantable […]
December 6, 2022
Simone Rudolph-Shortt Dec 2022 Quality by Design is defined as is a science and risk-based approach to ensuring consistent quality is achieved in a process or […]
August 17, 2021
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 […]