| AMMI recently held its Industry Expert Series Training Course on Medical Device Design Control at E&O Hotel, Penang. The course was attended by 25 participants.
The 2-day course examined the basic elements of regulatory requirements on medical devices and discusses examples of what systems are needed to be in put in place in by medical device manufacturers. Participants gained an understanding of areas of focus (as well as areas of common non-conformity/ non-compliance by manufacturers) by ISO 13485 CAB auditors and US FDA plant inspections. Participants were led by accomplished tutor, Mr Tony Low, who has over 2 decades of practical experience in the subject matter gained from auditing, training and quality assurance as well as management system development activities. |
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