Regulatory Compliance & ISO 13485 (part of the PDC2 of Specialist Diploma in Biomedical & Pharmaceutical Engineering)

Training Provider: Nanyang Polytechnic
Course Reference: TGS-2024046583
S$579

About This Course

This is part of the PDC2 of Specialist Diploma in Biomedical & Pharmaceutical Engineering

This module offers a training duration of 15 hours.

What You'll Learn

 In this module, learners will learn how to interpret the requirements of ISO 13485, USA FDA 21CFR Part 820 and relevant EU regulations that covers regulatory controls at three key stages of the product life cycle of a medical device: pre-market, placing-on market, and post-market.

Entry Requirements

The admission requirements for public intake are:
1.  Candidates should have a recognised university degree or polytechnic diploma in engineering or science or other relevant disciplines.
2.  Candidates with degrees or diplomas in other (non-relevant) disciplines, who have relevant work experience (RWE) will be considered.
3.  applicants who do not meet the above entry requirements may be considered based on Recognition of Prior Learning (RPL) with evidence of at least 5 yeas of RWE; or supporting evidence of competency readiness.  Suitable applicants who are shortlisted may have to go through an interview and/or entrance test(s).  The Polytechnic reserves the right to shortlist and admit applicants.

Course Details

Duration 15 hours
Language English
Training Commitment Part Time
Total Enrolled New course
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