Certification is a critical component in the healthcare industry due to the risks medical products could pose to patients and healthcare providers. Hence, healthcare device manufacturers must consider safety from many aspects, such as usability, electrical safety, risk management, environmental and direct effects, software integration, and more. The regulatory environment varies, and there are differences between world markets.
Our webinar, “Bringing electromedical devices to the North American market”, will cover the following:
- The regulatory environments in Canada and the US
- North American legal requirements
- The US vs. Canada - differences in the product approval process
