Greetings!
A medical device rarely gets held back because the science isn’t strong. More often, it’s a decision. A classification that shifts the entire requirement. A document that doesn’t land the way it should. A submission that looks complete, but doesn’t move.
From the outside, the pathway in Canada appears structured. Classes are defined, regulations are documented, and the steps seem clear. But once you’re inside the process, it becomes a sequence of calls that determine whether something progresses smoothly or slows down without warning.
This 2-hour workshop is built around that reality. It walks through how medical devices are regulated under Health Canada, how risk-based classification actually shapes the pathway, and how market authorization is approached when these decisions are made in practice. The focus is on understanding not just what is required, but how it is applied, where submissions tend to face resistance, and how regulatory strategy supports both approval and what follows after.
The session is led by Cecile Cualing, a pharmacist and regulatory affairs professional who has worked across both pharmaceutical and medical device environments. Her experience spans Health Canada, the U.S. FDA, and notified bodies, but what distinguishes her approach is where she started. Her early work in pharmaceutical manufacturing, in formulation and quality control, shaped how she understands regulation today. It is not separate from development or production. It sits within it. That perspective carries through her regulatory work, where she has supported market authorization and lifecycle management in real settings, and it informs how she explains decisions that are often reduced to checklists.
All participants will receive a certificate of attendance upon completion. Register by April 23 to receive 20% off using code SAVE20. |
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