ISO 13485:2016 – Awareness & Implementation Training – 2 Days
Strengthen Quality. Ensure Compliance. Improve Medical Device Safety.
ISO 13485:2016 provides a structured quality management framework for medical device organisations to maintain product quality, meet regulatory requirements, and support patient safety.
Our 2-Day ISO 13485:2016 Awareness & Implementation Training provides participants with practical knowledge to understand and apply ISO 13485 requirements, including risk-based thinking, documentation, traceability, validation, product realisation, and control of nonconforming products.
The programme also covers regulatory expectations, post-market surveillance, and continual improvement to help organisations strengthen their quality management system and manage risks effectively.
Who Should Attend
Medical Device Quality Professionals, QA/QC Managers & Executives, Regulatory & Compliance Personnel, Production & Manufacturing Personnel, and professionals involved in medical device quality management systems.
Key Outcomes
Participants will understand ISO 13485:2016 requirements, apply risk-based thinking, strengthen documentation and traceability, support validation and product realisation, manage nonconforming products, and contribute to post-market surveillance and continual improvement.
Quality in medical devices is not just about compliance—it is about protecting patients and building trust.
Enquiries & Registration
For enquiries and training arrangement, please contact:
Email:
sales@advancesynergy.com.my
hr@advancesynergy.com.my
Iedayu@advancesynergy.com.my
Phone:
013-388 1716 & 019-3661716
