Medical Device Regulatory Management Certificate

Medtech represents a critical sector in today’s economy, and it is also one which is highly regulated. Besides being typically recession-proof, it is fascinating to witness how several parts of Medtech has experienced accelerated growth during the Covid-19 pandemic.

This online certificate course aims to provide fundamental medical device regulatory training to anyone who is already working within Medtech, or otherwise having an interest to enter the Medtech sector. This course is highly recommended to Medtech practitioners in other non-regulatory functions such as Commercial, R&D, Quality and Supply Chain, as having a fundamental understanding of regulatory will certainly benefit their own roles, since regulatory is often deeply aligned with the organisation’s growth strategy.

Course syllabus

Module 1 – Medtech opportunity: What are the Medtech impact, market size and companies

Module 2 – What is Regulatory Affairs

• RA needs in terms of compliance, treatment access and talent pool.
• What is RA roles
• What is “Regulatorism”

Module 3 – Regulatory Fundamentals: How to perform Product Registration?

• Module 3.1 – Medical Device Definition
• Module 3.2 – Product Risk Classification
• Module 3.3 – Product Documentation
• Module 3.4 – Manufacturing Plant identification
• Module 3.5 – Manufacturing Plant qualification (ISO 13485 and ISO 14971)

Module 4 – RA skills

• Module 4.1 – RA Career specific skills
• Module 4.2 – How to work with Regulators
• Module 4.3 – Project Acceleration
• Module 4.4 – Stakeholder Management

Module 5 – Practical sharing by industry experts

• ISO 13485 implementation sharing
• Product Registration submission demonstration