Arca Monitors watches FDA guidance and recalls, MDCG guidance, EU harmonised standards, field safety notices from national competent authorities and new literature. The changes that affect your products land in one feed.
Each new guidance document, notice or paper goes from detection to a finished response, with the source attached at every stage.
Choose your sources: FDA guidance and recalls, MDCG guidance, harmonised standards in the EU Official Journal, national field safety notices, MAUDE for your device codes or new literature for PMCF.
Scoped to youEvery update comes with a plain-language summary and a link to the original source. Filter, prioritize and assign owners from a single feed.
ActionableAssess the impact on your products and technical documentation, track the follow-up tasks and draft the response in the same place.
End-to-endUse Monitors to keep your own products current or to send updates to the manufacturers you advise.
Regulatory affairs and quality teams see new FDA and MDCG guidance and changes to harmonised standards for their markets. Post-market surveillance teams get new MAUDE reports and field safety notices from BfArM, ANSM, MHRA and Swissmedic for their device types.
Send manufacturer clients alerts and regular briefings on the guidance and standards that apply to their devices.
One feed instead of several monitoring tools. Monitors gives you a single regulatory feed scoped to your products, markets and sources.
