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
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 to choose from the courses available on the Training Exchange course directory.
GST Increment in 2024
Please note that the GST rate will be revised to 9% with effect from 1 Jan 2024, as such any payable course fees will be subjected to the new GST rate adjustments in 2024.
Note:
- The fees below are determined based on prevailing funding policies and subject to review and revision.
- Please refer to our FAQs for more information.
Ngee Ann Polytechnic reserves the right to reschedule/cancel any programme, modify the fees and amend information without prior notice.
| Applicants / Eligibility | Fees |
|---|---|
| Full course fee | $419.65 |
| Singaporeans aged below 40 qualified for SkillsFuture Funding | $125.90 |
| Singaporeans aged 40 & above qualified for SkillsFuture Mid-Career Enhanced Subsidy | $48.90 |
| Singaporeans qualified for Enhanced Training Support for SMEs | $48.90 |
| Singapore Permanent Residents & **LTVP+ qualified for SkillsFuture Funding | $125.90 |
| Singapore Permanent Residents & ##LTVP+ qualified for Enhanced Training Support for SMEs | $48.90 |
| Others (and Repeat Students) | $419.65 |