Food & Drug Administration to expand Quality Management System Requirements for Medical Devices effective February 2026

The majority of MedTech firms we advice have commercialization in the US market as a key element of their business and GTM strategy. This puts them directly under the jurisdiction of the US Food & Drug Administration, one of the most prominent and influential regulatory agencies in the medical device industry whose activities we monitor […]

Seven important factors MedTech and Digital Health companies should consider when selecting a Regulatory Affairs consulting provider

For startups developing the MedTech solutions that are shaping the future of healthcare the journey is long and fraught with challenges in all areas, including: product development, clinical validation, regulatory approval and clearance, and market readiness, to name a few. Even the most experienced teams will have difficulty acquiring the expertise necessary to successfully navigate […]

Centech Acceleration Fall 2022 Medtech Cohort Regulatory Affairs Workshop facilitated by BML Technology Managing Director Marc Saab

The Centech Montreal technology startup incubator and accelerator program has become one of the most active and successful programs of its type in the Montreal technology startup ecosystem and beyond. A non-profit organization, Centech supports high-tech companies and projects with high growth potential, from conceptualization to commercialization, thanks to a bold, collaborative and passionate ecosystem. […]