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Build expertise in global medical device regulations

The medical device regulatory landscape is undergoing significant transformation with the FDA¡¯s implementation of the Quality Management System Regulation (QMSR), global alignment to ISO 13485, and strengthened European oversight under the EU MDR. Professionals must be prepared to interpret requirements, implement effective systems, and ensure audit readiness in a globally regulated environment.

This specialization delivers practical, hands-on expertise in three integrated areas: QMSR and ISO 13485 interpretation, EU MDR compliance strategy, and risk-based, process driven quality systems audits.

Why global regulatory compliance skills matter

Regulatory compliance is critical to bringing safe and effective medical devices to market. As regulatory frameworks evolve, organizations need professionals who can:

• Translate complex regulatory requirements into operational quality systems
• Prepare organizations for global regulatory inspections and audits
• Ensure documentation, clinical evaluation, and post-market surveillance meet international standards

Professionals with expertise in QMSR, ISO 13485, and EU MDR compliance are increasingly in demand across medical device manufacturers, biotechnology firms, and regulatory consulting organizations.

What you will learn

After completing the Global Regulatory Compliance specialization students should be able to:

• Interpret and apply requirements of the Quality Management System Regulation (QMSR) and ISO 13485:2016
• Develop an EU MDR compliance strategy for documenting clinical evaluations, technical documentation, and post-market surveillance
• Plan, conduct, and document  risk-based, process-driven quality systems audits