Infera

Infera Health builds an AI-native compliance platform for medical device companies, combining requirements traceability, architecture records, ISO 14971 hazard analysis, verification protocols, release controls, and document management into one living system record. The platform imports requirements from PDFs, PRDs, images, or Jira, connects cloud and code architecture, and packages controlled documents for DHF/TD submissions under ISO 13485, ISO 14971, and IEC 62304. Infera serves early-stage startups through global enterprises that need FDA-ready templates and centralized management of complex product portfolios.