Pragmatic regulatory approaches for medical devices
March 9, 2022
WATERLOO, Ont. – Healthcare is a growing area of business, and new medical device and system innovations are emerging. The regulations and standards in the area of medical devices are trying to keep up with product innovations but are written with hardware concepts in mind. It is up to the quality and regulatory representatives of an organization to understand and apply the regulations and standards to their products. There are some key ways of approaching this area of quality and regulatory in medical devices with a pragmatic mindset and flexible way of thinking that can save time and effort.
Session 1 – Introduction to the course, and the definition of medical devices.
Session 2 – Regulatory Classification and pathways – real-world examples; Medical Device Single Audit Program (MDSAP).
Session 3 – Building your first QMS and management commitment.
Session 4 – Practical considerations for process mapping and procedures.
Session 5 – Pragmatic approach to compliance with regulations.
Session 6 – Engagement of the entire organization in quality consideration.
Session 7 – Risk Management concepts, Failure Mode and Analysis Effects Analysis (FMEA).
Session 8 – Software tools and agile software development.
Session 9 – Measuring and monitoring results, Key Performance Indicators (KPI), Management Review.
Session 10 – Security, Privacy, Legal, and Ethical Requirements and considerations.
Upon successful completion, you will be awarded:
- A NIHI – McMaster CE Certificate of Attendance, based largely on attendance and homework submitted.
- A micro-credential, often referred to as a digital badge that verifies the skills and competencies earned. The digital badge can be displayed, accessed, and verified online in a resume, portfolio, website such as LinkedIn or other online platform.
Instructor: Christie Eby (pictured), Director, Process Excellence, Quality Regulatory, Intellijoint Surgical
NIHI – McMaster CE Pragmatic Quality & Regulatory Approaches for Medical Devices
Weekly, Tuesdays , April 5 – June 7 , 2022 | Live, Interactive, Online via Webex
10 Sessions, 11:50 – 1:00 PM ET
Competencies Achieved Upon Completion of Course:
- Identify a Regulatory Strategy for an existing or new product.
- Create an outline of a Quality Management System for Hardware and/or Software Products.
- Apply best practices on a pragmatic approach to Regulations and Standards.