Products
-
FDA Cybersecurity Labeling Requirements
Digital downloadThis guide decodes FDA cyber device labeling expectations, providing a checklist to ensure compliance. It helps regulatory and engineering teams verify required security documentation and user instructions to streamline premarket submissions.
Free
-
Cybersecurity evaluations for medical devices
Digital downloadThis guide helps teams navigate FDA, UL 2900, and IEC 81001-5-1 requirements. It includes a standards mapping table, a premarket submission checklist, and strategies for the 4 layers of security testing to ensure regulatory alignment.
Free
-
Parameter Diagrams for Robust Design
Digital downloadParameter Diagrams for Robust Design offers a systematic way to prevent late-stage failures. It includes an auto-calculating Excel template, guidance on 5 noise factor categories, and methods to link data to Design Inputs and FMEA.
Free
-
Design Review Scorecard Guide
Digital downloadStop "box-checking" and start improving outcomes with this Design Review Audit Kit. Includes Word scorecard using 18 criteria across 5 dimensions. Get objective scoring guidance and clear action-based thresholds.
Free
-
Design and development process controls that actually work
Digital downloadHow to stop treating Design Controls as a checkbox exercise— and start using them to prevent costly rework
Free
-
FDA Cybersecurity Requirements Decoded
Digital downloadThis guide, FDA Cybersecurity Requirements Decoded, provides a pragmatic roadmap for medical device teams to understand mandatory submission elements and common compliance gaps. It also provides a readiness checklist to ensure successful clearance.
Free