This training is one hour long on preparing Post-Market Surveillance Summary Reports for compliance with SOR/2020-262. This new Canadian regulation came into effect on December 23, 2021, the same day Rob Packard conducted the live webinar. This training features just over an hour of video from the live webinar. In addition, a combination of text, graphics, and downloadable reference materials are provided to capture multiple learning styles. The overall length of this training should be approximately 1.5-2 hours in length.
Below is a short video introducing and explaining what is addressed during this training. This video was published on our Youtube Channel for Medical Device Academy on December 23rd, 2021 announcing the live webinar.
After completing this Post-Market Surveillance Summary Reporting (for compliance with Health Canada), students should have an understanding of the concepts of SOR/2020-262 as well as strategies to prevent missing future regulatory changes from Health Canada and how to prepare a quality system plan for implementing the new SOR/2020-262.
Preparing a Post-Market Surveillance Summary Report and updating your Risk Management File, including the Benefit/Risk Analysis, is also addressed.
Successful completion of the final test at the end of the training will also provide an objectively demonstratable training record that can be used as initial training or competency maintenance.
No prerequisites are necessary for this training, but a prior understanding of Post-Market Surveillance and Health Canada regulations is helpful.
Rob is the founder and President of Medical Device Academy. The company was incorporated in October 2013, but he wasn’t smart enough to get some full-time help until 2017. As a result, Rob is constantly doing everything to extremes. That includes Zoom meetings with Austria, Sweden, Netherlands, and Israel at 6 am; and Skype calls with China and Australia and 10 pm. He, of course, “balances” this out with two and three workouts a day and a good novel until midnight. The picture above shows Rob at the end of a training hike with his dad (77 years old). I wonder where he gets his extreme personality from?
Phone: (802) 258-1881