Tools designed to support your development process.
⚠️ These tools are still under development and have not been validated. Please be sure to double check the results!
Available Tools
9
Coming Soon
3
Template Packs
3
Guides & Examples
12+
Failure Mode and Effects Analysis for ISO 14971 Risk Management
Visualize and analyze probability distributions for validation studies
Calculate required sample sizes for validation and clinical studies
MTBF calculations and device lifetime predictions
Statistical Process Control for manufacturing quality monitoring
Plan and analyze factorial experiments and response surface studies
Calculate Maximum Permissible Exposure (MPE) and Nominal Ocular Hazard Distance (NOHD)
Interactive diagram tool for IEC 62304 software safety classification
Visual decision tool for when to notify test labs or regulatory bodies
Determine FDA device class and regulatory controls
Determine appropriate FDA submission pathway (510k, PMA, De Novo)
Determine if your device is a "cyber device" per FDA 524B requirements
Ready-to-use templates for all skill levels
Excel/PDF plug-and-play templates
Excel workbooks with built-in formulas
Python/R code for advanced analysis
Comprehensive guides teaching you how to apply these tools to real medical device development scenarios.
Complete guide to ISO 14971 risk management using FMEA methodology
Understanding when to use normal, Weibull, exponential, and gamma distributions
FDA-compliant sample size determination for validation studies
Understanding MPE, NOHD, and laser classification requirements