MedTech by 10xAnd

Look up FDA 510(k) clearances, device classifications, MAUDE adverse-event reports and FDA-recognized consensus standards, parse UDIs, lay out a development roadmap for a device idea, compare sterilization methods, plan an ASTM F1980 accelerated aging study, and get budgetary cost and lead-time bands for prototype parts, drawings and whole bills of materials, with a ranked list of suppliers. Every FDA result states the query it ran and the date of the data. Quotes are estimates from a cost model, not supplier prices. For engineering, regulatory and sourcing work; not medical advice. What you can ask: find predicate devices and a product code's 510(k) history; look up a device's class and regulation; see what goes wrong with a type of device in MAUDE, including how many reports are duplicates of the same event; find the FDA-recognized standards for a product code; check a UDI; pick a sterilization method and its validation standards; work out how many chamber days an accelerated aging study needs; sketch a development program for a device idea, with its likely FDA pathway, phases, timeline and cost ranges; price a part from its description or an attached drawing; cost a whole bill of materials line by line; and rank suppliers for a process near a location. Results appear inline as charts, tables, cost bands and supplier cards, each with a link to the full tool on 10xand.com. Limits: every tool is read-only. The app does not place orders, contact suppliers, or store anything you send. MAUDE report counts are not rates and do not show that a device caused an event. Supplier listings come from public sources and are not endorsements. For firm quotes under NDA, use the request form on 10xand.com. 10xAnd is a registered assumed name of Alex Houck Consulting, LLC (Minnesota).

Look up FDA 510(k) clearances, device classifications, MAUDE adverse-event reports and FDA-recognized consensus standards, parse UDIs, lay out a development roadmap for a device idea, compare sterilization methods, plan an ASTM F1980 accelerated aging study, and get budgetary cost and lead-time bands for prototype parts, drawings and whole bills of materials, with a ranked list of suppliers. Every FDA result states the query it ran and the date of the data. Quotes are estimates from a cost model, not supplier prices. For engineering, regulatory and sourcing work; not medical advice.