ISO13485:2016 – Quality Management System for Medical Devices

Short Course / 1 day

Course Information
Learning Outcomes
Course Schedule
Lesson Plan
Course Fees

Course Information

ISO 13485 provides guidance enabling medical device manufacturers to develop a quality management system for ensuring the quality, safety and effectiveness of medical devices. Adoption of ISO 13485 allows an organization to ensure quality and safety of medical devices in terms of their design and development, production, installation and servicing of medical devices. This course will provide participants with understanding of ISO13486:2016, its applications and implementation and the major differences between ISO13485:2016 and ISO13485:2003.
This course is suitable for persons involved in:

  • Process Development Engineer
  • QC/QC/Regulatory Affair Specialist/Manage
  • Manufacturing/Validation associates
  • Quality Control Lab Analyst/Chemist
  • Production Engineer/Biotechnologist/Supervisor
  • Internal Auditors
  • Document controllers
  • Associates involved in the product life-cycle (medical devices)

Learning Outcomes

  • The purpose of ISO13486:2016
  • The key ISO13485:2016 terminologies
  • The requirements in ISO 13485:2016
  • The differences in ISO13485:2016 compared to ISO13485:2003
  • Your contribution in the QMS


Course Date: TBC
Duration: 1 day
Time: 9am to 6pm

Ngee Ann Polytechnic reserves the right to reschedule / cancel any programme, modify the fees and amend information without prior notice.

Lesson Plan

This course consists of 1 modules:

Course participants will gain a full understanding of the regulations set by ISO13485 to ensure the quality and safety of medical devices in terms of their design and development, production, installation and servicing. This course informs participants of the applications and implementation of ISO13486:2016, as well as the key differences between ISO13485:2016 and ISO13485:2003.


A Certificate of Performance will be awarded to participants who achieve at least 75% attendance and pass all required assessment(s).

Course Fees

Course fee is payable upon acceptance. It is inclusive of 7% GST and subject to review.

The course is eligible for SkillsFuture Credit.

Enter SME in the promo code during course application.

Applicants / Eligibility Fees
Singapore Citizens (SC) below the age of 40 years$123.59
Singapore Citizens (SC) aged 40 and above$46.59
Singapore Permanent Residents (PR)$123.59
Enhanced Training Support for SME Scheme (for SC & SPR)$46.59
Others (and Repeat Students)$411.95
Full Course Fee$411.95