{"product_id":"custom-iq-oq-pq-process-validation-package","title":"Custom IQ\/OQ\/PQ Process Validation Package","description":"\u003cp\u003eM4D LLC delivers a complete IQ\/OQ\/PQ validation dossier for one catheter manufacturing process at their ISO 13485:2016-certified, FDA-registered Lake Forest, CA facility. The package covers equipment qualification (IQ), worst-case bracket testing in triplicate (OQ), and three consecutive nominal production runs with Cpk ≥1.33 statistical summary (PQ) — all documented in QCBD QMS per FDA 21 CFR Part 820.75 and ISO 13485 §7.5.1, with a signed Validation Summary Report formatted for direct DHF and 510(k) integration.\u003c\/p\u003e\u003cp\u003e\u003cimg src=\"generation:\/\/5bfb861f-616b-451c-ac76-738852600b69\" alt=\"IQ\/OQ\/PQ binder set on brushed-aluminum table with M4D-branded covers, signed CoV, and USB evidence drive\"\u003e\u003c\/p\u003e\u003cp\u003e\u003cimg src=\"generation:\/\/7d765c7d-841e-4146-a175-7aabf3284e48\" alt=\"M4D engineers reviewing validation protocol binders in conference room at whiteboard\"\u003e\u003c\/p\u003e\u003cp\u003e\u003cimg src=\"generation:\/\/58a56121-94b1-43fa-a7b4-5b983cccb9ad\" alt=\"QCBD screen showing open deviation record with Approved disposition status\"\u003e\u003c\/p\u003e\u003ctable\u003e\n\u003cthead\u003e\u003ctr\u003e\n\u003cth\u003eQualification Summary\u003c\/th\u003e\n\u003cth\u003e\u003c\/th\u003e\n\u003c\/tr\u003e\u003c\/thead\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003ctd\u003eRegulatory Basis\u003c\/td\u003e\n\u003ctd\u003eFDA 21 CFR Part 820.75, ISO 13485:2016 §7.5.1\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003eOQ Design\u003c\/td\u003e\n\u003ctd\u003eWorst-case bracket testing, triplicate runs per condition\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003ePQ Statistics\u003c\/td\u003e\n\u003ctd\u003e3 consecutive nominal production runs, Cpk ≥1.33 per critical parameter\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003eDeviation Management\u003c\/td\u003e\n\u003ctd\u003eQCBD QMS deviation records, disposition tracked and approved\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003eFinal Report Format\u003c\/td\u003e\n\u003ctd\u003eSigned Validation Summary Report, DHF- and 510(k)-ready\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003eDelivery Timeline\u003c\/td\u003e\n\u003ctd\u003eQuoted per process scope; typically 6–8 weeks from kickoff\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003c\/tbody\u003e\n\u003c\/table\u003e","brand":"M4D LLC","offers":[{"title":"Default Title","offer_id":50374000279719,"sku":null,"price":3499.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0754\/8842\/8199\/files\/image_4659c2b8-9c9e-4e06-a488-4a01a3d3a28d.png?v=1779883871","url":"https:\/\/m4dally.com\/products\/custom-iq-oq-pq-process-validation-package","provider":"M4D LLC","version":"1.0","type":"link"}