CER and PMCF literature reviews
Screen papers against your inclusion and exclusion criteria, then extract device, population, endpoints, adverse events, and an appraisal into a shared review table.
Learn moreSolutions / Medical Devices
Arca for Medical Devices
Research device pathways, review clinical literature, and draft technical documentation with the evidence linked back to source.
Medical device teams
From evidence to a draft your team can review.
Predicate device research
Search FDA 510(k) clearances and compare device records to support predicate research and substantial equivalence discussions.
Learn moreVigilance and guidance monitoring
Follow new MAUDE reports, FDA and MDCG guidance, and field safety notices relevant to your device types and markets.
Learn moreArca supports research and drafting. Your team reviews the evidence and remains responsible for the final document and regulatory decisions.
Connected to your workYour documents. Published evidence.