Get up to speed on medical device regulations

WATERLOO, Ont. – Healthcare is a growing area of business, and new medical device and system innovations are emerging. However, it’s up to the quality and regulatory representatives of an organization to understand and apply the regulations and standards to their products.

In this new course from NIHI-McMaster, the sessions will focus on exploring quality systems and will provide tools and best practices to acquire and maintain certifications in the regulated environment of medical devices. The course takes a pragmatic approach to quality systems, using real-world case studies.

Pragmatic Quality & Regulatory Approaches for Medical Devices
10 Sessions, 10 Hours.
Live. Interactive. Online
Weekly October 7 – December 9, 2021 | 12:00 – 1:00 PM ET

Topics covered:

• Regulatory Classification and pathways – real-world examples; Medical Device Single Audit Program (MDSAP).
• Building your first QMS and management commitment.
• Practical considerations for process mapping and procedures.
• Pragmatic approach to compliance with regulations.
• Measuring and monitoring results, Key Performance Indicators (KPI), Management Review.

Recognition for Successful Course Completion

Certificate of Attendance: Upon completion you will be awarded a NIHI – McMaster CE Certificate of Attendance in Clinical Fundamentals for Non-Clinicians: The Care of the Health of the Body. A certificate of attendance is a non-academic certificate acknowledging that the recipient has completed a minimum of 10 hours of education/training in the subject area.

Micro-Credential: Upon successful completion of a course, you will receive a digital credential that can be shared electronically.

Registration And More Information

Learn from one of Canada’s leading quality and regulatory specialists:

Christie Eby (pictured), Director, Process Excellence, Quality Regulatory, Intellijoint Surgical, brings over 20 years of experience in the health IT field, in the areas of: Medical Device Regulatory, Quality Systems, Change Management, Process Improvement, Facilitation, Software Development and HR. Christie has recently joined Intellijoint Surgical as Director, Process Excellence, Quality Regulatory. For the previous 10 years she was part of the management team at Client Outlook Inc., purchased by Mach7 Technologies in July 2020.