Course Overview

ISO 13485:2016 is the global QMS standard for medical devices – required by EU MDR, US FDA QSR, and most national regulators. This Foundation course explains the standard’s structure, the regulatory drivers behind it, and the key differences from ISO 9001. A practical, focused day for anyone entering MedTech quality.

Who Should Attend

• MedTech professionals (RA/QA, design, manufacturing)
• Device manufacturers and contract manufacturers
• Suppliers to the MedTech industry
• Consultants entering the MedTech space

What You Will Learn

• Explain the structure, scope, and intent of ISO 13485:2016
• Apply design controls and link them to risk management (ISO 14971)
• Recognize traceability, validation, and post-market surveillance needs
• Identify key differences between ISO 13485:2016 and ISO 9001:2015
• Understand the alignment with EU MDR, US FDA QSR, and global regulations

Course Content

• MedTech regulatory landscape (FDA, EU MDR, MDSAP)
• ISO 13485:2016 clause-by-clause walkthrough
• Design controls and risk management (ISO 14971)
• Validation, verification, and traceability
• Post-market surveillance and CAPA at a foundational level

Methodology

Trainer-led delivery supported by group discussion and real-world examples drawn from device manufacturers, contract manufacturers, and MedTech suppliers.

Assessment

Participation is monitored throughout the day. No formal examination is conducted at the foundation level.

Certificate

Prerequisites