SaMD and AI / ML succeed when clinical intent, software behavior, model behavior, and validation evidence line up without gaps in logic. The work begins by translating intended use into explicit functional and performance claims, user and system requirements, and a risk picture that reflects both software and model failure modes. whether that is a 510(k), De Novo, PMA, Breakthrough Devices designation support, or other applicable regulatory pathways and submission types. For AI / ML, data provenance, partitioning, and representativeness matter, as do bias checks, subgroup performance, and guardrails for out-of-scope inputs. Verification proves the code and pipelines meet requirements. Validation proves the product supports safe and effective use in the real context of care. Usability, security posture, logging, and update mechanics are part of the product story, not afterthoughts.
HIC builds SaMD and AI strategies that make that story coherent. Our veteran software and data regulatory professionals, together with former FDA and CDRH reviewers, map functions and claims to regulatory status and submission type, right-size the software documentation level, and define validation that ties hazards and model risks to acceptance criteria. For AI, they establish data governance, pre-specified performance targets, generalization plans, and monitoring with clear triggers for rollback. Traceability runs from user needs to tests and release notes, including datasets, pipelines, and model versions. Configuration items, interfaces, SOUP, and anomaly handling are controlled, ensuring the build you submit is the build you ship. Change control, versioning, and predetermined change control plans (PCCP) support planned modifications while maintaining reasonable assurance of safety and effectiveness. The result is a lifecycle that regulators can rely on and that your team can operate at speed.
AI claims that withstand regulatory scrutiny
- We align claims and intended use to the correct regulatory status and submission type, then right-size documentation level and interaction strategy.
- Our specialists implement IEC 62304 lifecycle controls and ISO 14971 risk management, integrate IEC 82304-1 safety cases and IEC 62366-1 usability, and structure traceability from requirements to tests.
- We design verification and validation that link hazards and model risks to acceptance criteria, govern SOUP and interfaces, and produce inspection-ready cybersecurity and data governance documentation consistent with FDA expectations.
- Through disciplined change control and predetermined change control plans, we support post-market updates and model refreshes without undermining cleared claims.
