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
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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.
Certification
Certification
A Certificate of Performance will be awarded to participants who achieve at least 75% attendance and pass all required assessment(s).
Entry Requirements
Course Fees
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.
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 |
|---|---|
| Full course fees | $411.95 |