Four engineers around a conference table reviewing a catheter prototype, one annotating a cross-section drawing on a large monitor, M4D-branded materials, professional office setting

Full Catheter Design-to-Manufacture Program | Concept to Commercialization — Design, Prototype, V&V, Production

$5,800.00
$5,800.00
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Four engineers around a conference table reviewing a catheter prototype, one annotating a cross-section drawing on a large monitor, M4D-branded materials, professional office setting
  • Four engineers around a conference table reviewing a catheter prototype, one annotating a cross-section drawing on a large monitor, M4D-branded materials, professional office setting
  • M4D engineer and two academic researchers examining a first-article catheter prototype under a stereo microscope, engineering drawings and test fixtures on bench, open notebook with dimensional data
  • Close-up 8x magnification of thermally bonded zone between Pebax 55D jacket and Nylon 12 balloon cone, no void or delamination visible
  • Four engineers around a conference table reviewing a catheter prototype, one annotating a cross-section drawing on a large monitor, M4D-branded materials, professional office setting
  • M4D engineer and two academic researchers examining a first-article catheter prototype under a stereo microscope, engineering drawings and test fixtures on bench, open notebook with dimensional data
  • Close-up 8x magnification of thermally bonded zone between Pebax 55D jacket and Nylon 12 balloon cone, no void or delamination visible
Full Catheter Design-to-Manufacture Program | Concept to Commercialization — Design, Prototype, V&V, Production

Full Catheter Design-to-Manufacture Program | Concept to Commercialization — Design, Prototype, V&V, Production

$5,800.00
$5,800.00

M4D 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.

Engineering Data
Program Phases 5: Design Inputs → Concept → Prototype → V&V → Production Transfer
Design Controls ISO 13485:2016 DHF-aligned, QCBD QMS throughout
Prototype Materials Production-intent (Pebax, PTFE, Nylon 12, SS/Nitinol braid, Pt markers)
Adhesives UV (365 nm, Dymax equiv.) / Cyanoacrylate (<5 cP) / Epoxy per design
Testing Standards ASTM F2504, ISO 10555, ISO 10993-1, ISO 11135 (EtO)
V&V Documentation IQ/OQ/PQ protocols, signed test reports, 510(k)-ready
Production Deliverables Process traveler, work instructions, UDI/lot traceability, yield baseline
Team Experience 70+ years combined endovascular catheter engineering
Location Lake Forest, CA
Regulatory ISO 13485:2016, FDA Registered Facility, QCBD QMS

Program 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.

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