medical device

April 23, 2026

Need a Medical Device Technical Expert or Authorised Representative

contact www.isohealthsa.co.za A Technical Expert ensures medical devices meet stringent regulatory, safety, and performance standards. Their role covers: An Authorised Representative (AR) acts as the legal […]
December 19, 2022

MDR, IS AN EXTENSION THE RIGHT DECISION

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 […]