ISO13485:2016 – Quality Management System for Medical Devices

Offered by School of Life Sciences & Chemical Technology

Short Course / 1 day / TGS-2019507792

Course Information
Learning Outcomes
Course Schedule
Lesson Plan
Trainer Profile
Certification
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)

Note: You are strongly encouraged to bring along you own copy of the ISO 13485 (hard or soft copy) avoid sharing as much as possible

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 
Schedule

Course Date: TBC
Application: TBC
Duration: 1 day
Time: 9am to 6pm
Delivery Mode: Classroom
Venue: Ngee Ann Polytechnic

This course may be conducted online subject to Covid-19 guidelines.

You are strongly encouraged to bring along you own copy of the ISO 13485 (hard or soft copy) avoid sharing as much as possible.

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

Lesson Plan

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.

Trainer's Profile

Agnes Lim

Ms AGNES LIM is a master trainer with over 25 years QA/RA experience. She gained the experience from her role as the QA/RA manager in GSK, Head of Quality (Contact lens) in Alcon and then Novartis Singapore (Pharmaceutical Manufacturing).

Expert in GMP compliance, she has hosted scores of regulatory inspections from different regulatory agencies ranging from local HSA, US FDA, PMDA (Japan), KFDA (Korea)  and  Eastern  European health authorities and notified body audits for ISO13485.

She is also very well versed in the quality systems, GMP guidelines and ISO guideline eg PICs, ICH guidelines, EU GMP, ISO 13485 and ISO 14971. She is an ISO 9001 and ISO13485 auditor, has been a lead auditor in her former companies and has led and performed numerous internal and external audits.

Certification

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


Course Fees

Funding period for this course is from 12 May 2019 to 30 Sep 2024. 

SkillsFuture Credit
All Singaporeans aged 25 and above can use their $500 SkillsFuture Credit from the government to pay for a wide range of approved skills-related courses. Visit the SkillsFuture Credit website (www.skillsfuture.sg/credit) to choose from the courses available on the Training Exchange course directory.

Union Training Assistance Programme (UTAP)
NTUC members enjoy 50% unfunded course fee support for up to $250 each year (or up to $500 for NTUC members aged 40 years old and above) when you sign up for courses supported under UTAP (Union Training Assistance Programme). Please visit e2i’s website to find out more.

Enhanced training support for SMEs
For enhanced training support for SMEs, enter SME in the promo code during course application.

Long Term Visit Pass Plus (LTVP+) Holders
Please furnish the following documents to the course administrator to qualify for SSG funding:

  1. Self-sponsored learner (**LTVP+): Copy of your green visit pass card, with the word ‘PLUS’ on the back of the card.
  2. Co-sponsored learner (##LTVP+): Copy of valid and current Letter of Consent (LOC) from MOM

 

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

 

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

 

Applicants / Eligibility Fees
Singapore Citizens (SC) aged 40 and above$46.59
Enhanced Training Support for SME Scheme (for SC & SPR)$46.59
Others (and Repeat Students)$411.95
Full course fees$411.95
Singaporeans aged below 40, Permanent Residents & **LTVP+ qualified for SkillsFuture Funding$123.59
Singaporeans aged 40 & above qualified for SkillsFuture Mid-Career Enhanced Subsidy$46.59
Singaporeans, Permanent Residents & ##LTVP+ qualified for Enhanced Training Support for SMEs$46.59
Others (and Repeat Students)$411.95