MDIC CM&S Reference Hub
Key Resources for Computational Modeling & Simulation Across the Lifecycle
A living, curated index of consensus standards, qualified medical device development tools, FDA Guidance documents and other resources relevant for utilizing CM&S across the medical device lifecycle.
Computational modeling and simulation (CM&S) can be used for assessing medical device safety and/or effectiveness or be implemented within software in medical devices. On this page, you can access a curated, regularly updated database of US FDA CDRH Guidance documents, FDA-recognized consensus Standards, and other key resources relevant to CM&S for medical devices.
Scope Note: This reference hub is specifically focused on physics-based or mechanistic computational models, not data-driven models such as AI. The hub does not aim to cover documents related to AI, although some key resources are included. For information on Artificial Intelligence in Software as a Medical Device, please visit the FDA’s AI/ML SAMD resource page.
How to Use This Resource
Rather than presenting a static list of documents, the MDIC CM&S Reference Hub is built as an interactive, filterable database.
Users can easily isolate the exact regulatory pathways or technical frameworks relevant to their specific modeling application by using the primary drop-down filters:
Filter by Document Type
- Guidance: Formal regulatory frameworks and policies (e.g., FDA, PMDA, MHRA).
- Standard: Consensus-based engineering protocols (e.g., ASME, ASTM, ISO, IEC).
- Medical Device Development Tools (MDDT): FDA-qualified Medical Device Development Tools.
- Regulatory Science Tool (RST): Peer-reviewed tools, computational models, and validation datasets developed by CDRH’s Office of Science and Engineering Laboratories (OSEL).
- Report & White Paper: Broad landscape surveys and position papers.
- Informational Resource: Agency landing pages and program overviews.
Filter by Applicability Scope
- Application-Specific: Documents tied to a targeted clinical discipline or specific device type (e.g., orthopedic stems, cardiovascular valves, MR safety).
- General Framework: Foundational methodology documents (like ASME V&V 40 or FDA Credibility guidelines) that apply broadly across devices.
- Supporting Context: Adjacent digital health, SaMD, and regulatory resources that provide crucial context but are not explicitly focused on modeling.
Legal & Regulatory Disclaimer The resources compiled in this database are provided by the Medical Device Innovation Consortium (MDIC) for informational and educational purposes only. While MDIC strives to maintain an accurate and up-to-date curated list of CM&S materials, this page is not an exhaustive inventory of all available guidance documents, standards, or tools. This repository does not constitute official regulatory, legal, or engineering advice. Stakeholders should always consult directly with the U.S. FDA, CDRH, or the respective standards development organizations for the most current and authoritative regulatory requirements.
Contact & Feedback For inquiries, suggestions for new additions to the database, or general updates, please reach out to cms@mdic.org. For more information on digital health and technology initiatives, visit www.mdic.org.
*Updated as of July 13, 2026