Three printed IQ/OQ/PQ validation binders on brushed-aluminum table with M4D-branded covers, signed Certificate of Validation, and USB evidence drive

Custom IQ/OQ/PQ Process Validation Package

$3,499.00
$3,499.00
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Three printed IQ/OQ/PQ validation binders on brushed-aluminum table with M4D-branded covers, signed Certificate of Validation, and USB evidence drive
  • Three printed IQ/OQ/PQ validation binders on brushed-aluminum table with M4D-branded covers, signed Certificate of Validation, and USB evidence drive
  • M4D engineers in conference room reviewing IQ/OQ/PQ validation protocol binders at a whiteboard
  • QCBD QMS screen showing open deviation record with Approved disposition status in a cleanroom office setting
  • Three printed IQ/OQ/PQ validation binders on brushed-aluminum table with M4D-branded covers, signed Certificate of Validation, and USB evidence drive
  • M4D engineers in conference room reviewing IQ/OQ/PQ validation protocol binders at a whiteboard
  • QCBD QMS screen showing open deviation record with Approved disposition status in a cleanroom office setting
Custom IQ/OQ/PQ Process Validation Package

Custom IQ/OQ/PQ Process Validation Package

$3,499.00
$3,499.00

M4D 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.

IQ/OQ/PQ binder set on brushed-aluminum table with M4D-branded covers, signed CoV, and USB evidence drive

M4D engineers reviewing validation protocol binders in conference room at whiteboard

QCBD screen showing open deviation record with Approved disposition status

Qualification Summary
Regulatory Basis FDA 21 CFR Part 820.75, ISO 13485:2016 §7.5.1
OQ Design Worst-case bracket testing, triplicate runs per condition
PQ Statistics 3 consecutive nominal production runs, Cpk ≥1.33 per critical parameter
Deviation Management QCBD QMS deviation records, disposition tracked and approved
Final Report Format Signed Validation Summary Report, DHF- and 510(k)-ready
Delivery Timeline Quoted per process scope; typically 6–8 weeks from kickoff

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