ISO13485 for Beginners - The Requirements Made Simple
Tue, 21 Apr
|Holiday Villa, Subang
Let's understand what and how Medical Device QMS should be understood. We will unveil what most auditors will ask when it comes to ISO13485 compliance.
Time & Location
21 Apr 2026, 9:00 am – 5:00 pm
Holiday Villa, Subang, Persiaran Wangsa Baiduri 12/1, Ss 12, 47500 Subang Jaya, Selangor, Malaysia
About the Event
This is the continuity of the FREE Seminar Series on ISO13485 subject.
In Part 1, we have learned the overview of the Medical Device QMS and how its interpretation. In this round, we will be interpreting the entire Clauses within the ISO13485 Standard. Lets go through auditor's favourite questions and possible loop holes in the implementation. In this session, we will be showing a real analysis from previous audit findings related to medical device and how to avoid those NCs.