ISO 13485: 2016 Medical Device QMS Requirements

Medical device quality management system (mdqms) is a structured system of procedures and processes covering all aspects of design, manufacturing, supplier management, risk management, complaint handling, clinical data, storage, distribution, product labelling, and more. Most medical devices will r...

Elite provides gdpmd training and consultancy services. We offer specialized expertise and extensive practical experience to assist client in developing management systems from the initial concept to establishment and successful implementation of the management systems.

The course is ideally suited to those with knowledge of intermediate medical electronics equipment but lacking experience with intermediate biomedical systems. Participants will gain confidence in working with intermediate biomedical equipment by carrying out structured, practical session on equipm...

Gdpmd is a stipulated requirement under the malaysian medical device act 737 and its accompanying regulations affects parties involved in the distribution of medical devices. This course provides an introduction and interpretation of gdpmd and related guidelines.

This module is designed to introduce participants with the knowledge on classification of medical devices which are Class A, B, C and D. The process includes the classification of medical device and classification rules for medical devices. Participant will learn on the requirements of classificati...