FDA expects your Software as a Medical Device (SaMD) company to have a robust, documented Quality Management System (QMS) — even in early stages. But traditional QMS frameworks are often overbuilt for nimble, software-driven teams.
This white paper breaks down how startup innovators can right-size a QMS for FDA compliance without slowing down product development. Learn how to implement a scalable, audit-ready QMS that supports your FDA submissions and your agile workflows.
- Built on ISO 13485 principles, streamlined for SaMD
- Focused on risk management, cybersecurity, and human factors
- Includes actionable templates and real-world examples
- Aligned with FDA guidance on design control and documentation
Download the white paper and future-proof your compliance strategy.
