We’re excited to announce that our Founder and Managing Director, Marc Saab conducted a Regulatory Outlook Roundtable in partnership with Raleigh, NC based DHIT, the Digital Health Institute for Transformation, that took take place on October 19th, 2022 at 4:30 PM in the North Carolina Research Triangle city of Raleigh. The event took place prior to the monthly DHIT Digital Health Happy Hour gathering.
At the Roundtable Marc shared insights and went over key concepts and critical considerations in Medical Device Regulatory Affairs (RA) and Quality Assurance (QA) for early-stage medical technology startups. Specific strategies for regulatory risk management, stepwise quality assurance development, and reaching incremental milestones with Health Canada and the FDA.
Attendees walked away better equipped to design their medical device product development and clinical validation strategies while integrating the appropriate Regulatory Affairs (RA) and Quality Assurance (QA) considerations at the right stages before they become hurdles.
Some of the specific challenges faced by medical technology startups to be addressed include:
- WHY A GREAT PRODUCT AND SIGNIFICANT FUNDING ARE NOT ENOUGH.
- WHY THE REGULATORY COMPLIANCE STRATEGY SHOULD BEGIN AT THE IDEATION STAGE.
- WHY MEDICAL DEVICE STARTUPS NEED A CUSTOMIZED REGULATORY STRATEGY.
About DHIT:
Enabling A World Without Health Inequity. DHIT is a non-profit education and research institute supporting communities through the process of digital health transformation. DHIT’s mission is to maximize health in underserved communities across the nation and beyond by providing equal access to global advancements in care.
About BML Technology
BML Technology understands digital health. At the intersection of medical technology, clinical research and patient-centric healthcare BML drives the mainstream adoption of digital technology in healthcare. Offering a full range of services to the digital health ecosystem BML manages the complex stakeholder interactions necessary to get digital health solutions to market and gain adoption.
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