A business QMS has realizable merits by Simone Rudolph-Shortt
February 4, 2026
contact www.isohealthsa.co.za
A Technical Expert ensures medical devices meet stringent regulatory, safety, and performance standards. Their role covers:
- Quality Management System (QMS) development and improvement
- Compliance oversight and risk management
- Clinical & Performance Evaluation
- Process and product validation
An Authorised Representative (AR) acts as the legal liaison between the manufacturer/distributor and the National Regulatory Authority, managing:
– Post-market surveillance and vigilance
– Adverse event reporting (AER)
-Product regulatory submissions and queries
Both roles are critical for compliance, market access, and patient safety. They also support staff development and training, ensuring organisations remain audit-ready and competitive in the healthcare sector.
