Good Distribution Practice for Medical Devices Interpretation (GDPMD)

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...

Internal audit is a mandatory requirement of ISO 13485 2016 as it mandates the review and evaluation of the organisation’s quality management system QMS to evaluate its conformity with the ISO 13485 stipulated requirements, compliance with applicable regulatory requirements and whether the proced...

This course is designed to provide participants with the awareness of the ISO 13485:2016 throughout the product life cycle of a medical device, with emphasize on the applicable regulatory requirements. Having completed this course, participants will gain the knowledge of ISO 13485:2016 and aware of

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...