Regulatory Changes and General Implications for Medical Device Manufacturers
April 15, 2026 at 12:00-1:00PM
The U.S. Food and Drug Administration transitioned from the Quality System Regulation to the Quality Management System Regulation (QMSR) on February 2, 2026, aligning the FDA’s requirements more closely with ISO 13485:2016. This regulatory shift will impact how medical device manufacturers prepare for and experience FDA inspections. This session will provide an overview of the regulatory transition and explore how FDA inspections may evolve during and after implementation of the new regulation. The topics will:
- Provide an educational overview of regulatory changes and general implications for medical device manufacturers.
- Provide an educational overview of regulatory changes and general implications for medical device manufacturers.
- Discuss considerations related to FDA inspections during the transition period.
- Discuss considerations related to FDA inspections during the transition period.
Presenter: Tyler Ting, MS, Rook Quality Systems:
Mr. Ting has a broad medical device experience including software as a medical device, implantable devices, and in-vitro diagnostics.
Mr. Ting began his professional journey with dual degrees in Biochemistry and Mechanical Engineering from CU Boulder, driven by a passion for healthcare innovation. He started as a project management intern at a medical device company and quickly realized the pivotal role of quality and regulatory teams in guiding MedTech innovation.
He progressed to leading software as a medical device (SaMD) projects, gaining mentorship that shaped his regulatory approach. Tyler later contributed to global leaders like Medtronic and Stryker, working on international regulatory submissions, U.S. post-market compliance, and EU MDR transitions.
During the COVID-19 pandemic, he joined an IVD startup, submitting an Emergency Use Authorization (EUA) for an antigen test. That experience sparked his passion for startups, leading him to consulting, where he has guided MedTech innovators for the past three years.
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