Regulatory Strategy
HMC helps medical device companies assess FDA submission options, including 510(k), investigational device exemption (IDE) and other product-specific routes. Review includes intended use, technology and the availability of a predicate device.
Regulatory Submission
HMC supports medical technology companies preparing FDA and European submission materials. Scope may include 510(k), Emergency Use Authorization (EUA) or In Vitro Diagnostic Medical Devices Regulation (IVDR) documentation, according to the product and applicable pathway.
FDA
HMC supports medical product companies with FDA development planning and submission preparation. Services are scoped to the product and applicable pathway, including 510(k), De Novo, premarket approval (PMA) or Emergency Use Authorization (EUA).
IVDR
HMC supports in vitro diagnostic manufacturers with technical documentation and quality-system planning under the European In Vitro Diagnostic Medical Devices Regulation (IVDR). The work supports applicable conformity assessment and CE marking preparation.
Original source: HMC service overview ↗
