Mastering Quality Systems: An ISO 13485 Course for Medical Device Professionals

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This rigorous course/webinar offers comprehensive instruction on medical device Quality Management System (QMS) requirements of ISO 13485:2016, which are now harmonized with the US Code of Federal Regulations (21 CFR Part 820) governing medical device development. Participants will gain the practical skills and critical knowledge needed to successfully establish, document, implement, and maintain a medical device QMS, ensuring compliance and quality across the device's full lifecycle.

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This training takes place in one of two formats (your choice): 

• Three-day in-person training (8 hours/day) located at your site

• Five-day remote online training (4 hours/day)

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Quality Management Systems for Medical Devices Course Objectives:

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After taking this course, you will be able to:

• Define the regulatory basis and requirements for a medical device QMS

• Apply ISO 13485:2016 requirements to device development in pre-market, design, and post-market phases

• Become familiar with the major QMS sub-systems

• Understand the interrelationship between Purchasing, Design Controls, Risk Management, and other sub-systems of the QMS

 

Who should take this course?

• Quality Engineers and device team members new to their jobs

• Team members that require proof of training in ISO 13485:2016 (certificate awarded at end of course)

• Experienced device professionals looking to brush up on regulations

• Recommended for professionals in QA/RA, R&D, Marketing, Production Management, and any role associated with the Quality Assurance / Quality control function

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Course Overview

 

Introduction to the QMS (Clauses 0 - 4)

• Definition of QMS and typical sub-systems

• Basics of US/EU medical device requirements

• Overview of ISO 13485:2016 (Clauses 0 - 4)

 

Management Responsibility & Resources (Clauses 5 - 6)

• Framework of Management responsibility

• Provision of resources

• Resource management

 

Product Realization (Clauses 7.1 - 7.3)

• Planning product realization under ISO 13485:2016

• Process requirements related to customers

• Design Controls under ISO 13845:2016

 

Product Realization, Part 2 (Clauses 7.4 - 7.6)

• Purchasing requirements under ISO 13485:2016

• Production and service provision requirements

• Measuring equipment and monitoring requirements

 

Measurement, Analysis, & Improvement (Clause 8)

• Complaint handling, feedback, and regulatory reporting

• Internal audits under ISO 13485:2016

• Monitoring & measuring processes and non-conforming product

• Analysis of data and continuous improvement

• Corrective and preventative action (CAPA)

 

Intersections with European Union Requirements

• EU MDR Article 10

• Requirements for EU-compliant QMS

• Notified body basics and audits

 

Global QMS and Audits

• Common elements in global QMS requirements

• QMS audit basics

• FDA/MDSAP and other inspection basics​

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