{"product_id":"full-catheter-design-to-manufacture-program-concept-to-commercialization-design-prototype-v-v-production","title":"Full Catheter Design-to-Manufacture Program | Concept to Commercialization — Design, Prototype, V\u0026V, Production","description":"\u003cp\u003eM4D LLC's Full Catheter Design-to-Manufacture Program is a complete catheter development engagement from design input through production transfer. Ideal for medical device startups, OEM line extensions, and university spinouts seeking a single ISO 13485-certified contract development and manufacturing organization (CDMO) for endovascular catheter programs.\u003c\/p\u003e\u003ctable\u003e\n\u003cthead\u003e\u003ctr\u003e\n\u003cth\u003eEngineering Data\u003c\/th\u003e\n\u003cth\u003e\u003c\/th\u003e\n\u003c\/tr\u003e\u003c\/thead\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003ctd\u003eProgram Phases\u003c\/td\u003e\n\u003ctd\u003e5: Design Inputs → Concept → Prototype → V\u0026amp;V → Production Transfer\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003eDesign Controls\u003c\/td\u003e\n\u003ctd\u003eISO 13485:2016 DHF-aligned, QCBD QMS throughout\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003ePrototype Materials\u003c\/td\u003e\n\u003ctd\u003eProduction-intent (Pebax, PTFE, Nylon 12, SS\/Nitinol braid, Pt markers)\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003eAdhesives\u003c\/td\u003e\n\u003ctd\u003eUV (365 nm, Dymax equiv.) \/ Cyanoacrylate (\u0026lt;5 cP) \/ Epoxy per design\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003eTesting Standards\u003c\/td\u003e\n\u003ctd\u003eASTM F2504, ISO 10555, ISO 10993-1, ISO 11135 (EtO)\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003eV\u0026amp;V Documentation\u003c\/td\u003e\n\u003ctd\u003eIQ\/OQ\/PQ protocols, signed test reports, 510(k)-ready\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003eProduction Deliverables\u003c\/td\u003e\n\u003ctd\u003eProcess traveler, work instructions, UDI\/lot traceability, yield baseline\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003eTeam Experience\u003c\/td\u003e\n\u003ctd\u003e70+ years combined endovascular catheter engineering\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003eLocation\u003c\/td\u003e\n\u003ctd\u003eLake Forest, CA\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003eRegulatory\u003c\/td\u003e\n\u003ctd\u003eISO 13485:2016, FDA Registered Facility, QCBD QMS\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003c\/tbody\u003e\n\u003c\/table\u003e\u003cp\u003eProgram entry at $5,800.00 covers Phase 1 (Design Inputs) and Phase 2 (Concept Design with formal design review). Phase pricing for Phases 3–5 quoted on project scope. Multi-phase programs available at fixed or time-and-materials pricing.\u003c\/p\u003e","brand":"M4D LLC","offers":[{"title":"Default Title","offer_id":50373754126503,"sku":null,"price":5800.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0754\/8842\/8199\/files\/image_49be0dc1-1711-4bb7-aa37-7b1b4f1a4720.png?v=1779883336","url":"https:\/\/m4dally.com\/products\/full-catheter-design-to-manufacture-program-concept-to-commercialization-design-prototype-v-v-production","provider":"M4D LLC","version":"1.0","type":"link"}