SPDF Templates
Secure Medical Devices Throughout Their Lifecycle with our Robust SPDF
Our Secure Product Development Framework (SPDF), which integrates seamlessly with your Quality Management System, helps you identify and reduce the number and severity of vulnerabilities in your products throughout their entire lifecycle.
The SPDF contains cybersecurity-specific procedures and templates that uniquely address your medical device cybersecurity requirements – essential since the Federal Food, Drug & Cosmetic Act mandates assurance that devices are cybersecure. With our SPDF, which covers all requirements and recommendations, you can meet quality system regulations and FDA expectations.
SPDF Services & Templates
Our services, cybersecurity SPDF procedures, templates and SPDF documentation package are based on FDA-recognized standards IEC 81001-5-1 and ANSI/AAMI SW96:2023, providing an excellent foundation for a risk-based cybersecurity QMS.
SPDF Procedures & Templates
25 procedures with 19 templates that guide SPDF activities for everything needed to successfully navigate an FDA inspection.
SPDF Manual
A Cybersecurity Management System manual for medical devices.
FDA Premarket Submission Templates
19 templates covering all required documentation that directly matches eSTAR terminology.