Compliance for Medical Technology Made Simple

Hardware Compliance covers FDA 510(k) and CE marking requirements for medical technology, alongside ISO standards that apply to your specific product category. The AI agents read and reason across the relevant regulatory standards bodies, surface every applicable requirement with full citations, and map them to your product specs. This means you get a complete picture of what your device must satisfy before you invest in testing, reducing the risk of surprises during the review process.

Traditional medical device compliance consultants bill by the hour and often take months to deliver research and documentation that Hardware Compliance's AI agents can produce in a fraction of the time. Hardware Compliance automates regulatory research, technical file drafting, hazard analysis, and lab matching. Expert review and sign-off by industry professionals is also included, so you get human accountability without paying consulting rates for every hour of document preparation.

Hardware Compliance auto-generates the technical documentation packages that testing labs and regulatory submissions require. This includes technical files, test plans aligned with applicable standards, hazard analysis and risk assessment documents, and declarations of conformity. All documents are drafted by AI and reviewed by industry professionals before submission, so your package arrives complete and correctly formatted the first time.

Hardware Compliance is well suited for teams navigating their first FDA 510(k) or CE marking process. The platform surfaces every applicable requirement with citations directly to the source text so your team can see exactly what applies and why. It then generates the required documentation and matches you with an accredited testing lab appropriate for your device type and target market, replacing the need to piece together the process from scratch.

Hardware Compliance's multi-market support maps FDA and CE marking requirements simultaneously, so medical technology teams launching in both the US and EU get a unified compliance plan rather than managing two separate processes. The platform covers the distinct documentation, testing, and submission requirements for each jurisdiction and highlights where they overlap or diverge, helping teams avoid duplicating work or missing market-specific obligations.