Regulatory Resources

MedTech Regulatory & Quality Resource Hub

The (MedTech) World Needs More Canada

Hello, Thanks for opening this 2nd issue of the Regulatory Raconteur, a monthly publication focusing on the impact of Regulatory and Quality Assurance on MedTech businesses with an emphasis on the Canadian ecosystem.

Regulatory Raconteur (Newsletter)

2023, Canadian MedTech and the Holidays!

This monthly publication will focus on the impact of Regulatory and Quality Assurance on MedTech businesses with a slight emphasis on the Canadian ecosystem.

Regulatory Raconteur (Newsletter)

Digital Health Taiwan: Fostering the best ecosystem

Taiwan occupies a unique position in the Asia-Pacific region. As a middle-income society, it is a suitable environment for incubating novel digitalization concepts. The market size is ideal for a first launch in Asia, the population well versed in technology, internet access is considered a human ri

Case Studies

Unregulated: A Diverse Regulatory Affairs Professional Story

I recently read an article on increasing Diversity in the Regulatory Affairs Profession. I was quite excited at first, and even more so when I saw a section dedicated to utilizing “new immigrant” talent for diversity purposes, only to find in cliché statements such as multilingualism and knowledge

Regulatory Raconteur (Newsletter)

Health Canada’s Annual Regulatory and Quality Conference: A personal digest

In a recent LinkedIn post, I spoke about Health Canada’s plan to make the REP (Regulatory Enrolment Process) mandatory 18 months after its projected implementation date (January 2024). In another post, I summarized the list of proposed amendments to the Canadian Medical Device Regulation, for which

Regulatory Raconteur (Newsletter)