Custom hypodermic-based medical devices from raw metal and polymer to sterile pack. One facility, one quality system, one design history file. Class I & II with low minimum order quantities — we scale with you from first production run to 500K+ units/year.
Every step from raw material to sterile finished good flows through a single continuous production system — no split programs, no inter-facility transfers, no wasted motion between vendors. One quality system, one value stream, one accountable team.
12 specialized processes: Ecut, point grind, swage, laser weld, etch, grit blast, CNC machine, TIG weld, buff, ultrasonic clean, electropolish, and laser cutting. Stainless steel wire, rod, and tubing transformed into precision components.
View specifications →Class 8 cleanroom plastics capability. Insert molding bonds metal + polymer into a single component. Standard and custom tooling for luer locks, stylet handles, cannula assemblies. Production-grade presses with automation.
View specifications →Ultrasonic cleaning with acidic, neutral, and alkaline cleaners. Triple cascading DI water rinse with HEPA-filtered drying. Descaling and passivation for chromium oxide formation on stainless steel.
Learn more →Class 7 cleanroom engineered for lean, high-mix production — 20+ concurrent programs with rapid changeovers and single-piece flow. Barcode-driven error-proofing (poka-yoke) linked to ERP for real-time traceability and pull-based workflow control.
Learn more →Exclusive partnership with STERIS — a globally recognized sterilization provider. Full EO cycle management including validation, testing, and transport. Pre-validated process eliminates vendor qualification for customers.
See sterilization advantage →Complete packaging to customer specifications with full inspection and documentation. Wide range of packaging methods ensuring product integrity from facility to clinical site. Labeled, sealed, and ready to ship.
Learn more →OEM engineers need specifications before the first call. Here's what our 12-process machine shop delivers — with full simulation verification and CAM-driven process optimization that has eliminated secondary operations across multiple product lines, reducing waste, cycle time, and cost per part.
| Capability | Detail |
|---|---|
| Materials | 304 & 316L stainless steel, specialty alloys |
| Stock Forms | Wire, rod, hypo tubing |
| CNC Machining | Swiss-type CNC, 2–5 axis |
| Cutting | Ecut, laser cutting |
| Grinding | Point grind — custom tip geometries |
| Welding | Laser weld, TIG weld |
| Surface Finishing | Electropolish, buff, grit blast, etch |
| Forming | Swage operations |
| Cleaning | Ultrasonic, passivation, triple DI rinse |
| Throughput | High-volume, multi-shift capable |
| Plastics | Overmolding, injection — Class 8 |
| Assembly | Class 7 cleanroom — high-mix capable |
Insert molding and overmolding are core to our platform — not an afterthought. Machined metal components move directly from our shop floor into the molding cell, eliminating inter-facility transfers, reducing handling risk, and keeping the entire device under one quality system.
From luer lock hubs and stylet handles to complex cannula assemblies, our tooling library and custom mold capabilities support both legacy products and new program launches.
| Capability | Detail |
|---|---|
| Processes | Insert molding, overmolding, injection molding |
| Environment | Class 8 (ISO 14644) cleanroom |
| Materials | Medical-grade thermoplastics (polycarbonate, ABS, nylon, HDPE, polypropylene) |
| Tooling | Standard library + custom molds; single & multi-cavity |
| Automation | Automated press cells with robotic part handling |
| Typical Components | Luer locks, stylet handles, cannula hubs, device housings |
| Integration | Direct feed from in-house metal machining — no inter-facility transfer |
| Quality | In-process dimensional inspection, SPC monitoring, full lot traceability |
Ranfac's standardized partnership with STERIS provides a meaningful competitive advantage by reducing regulatory and operational risk for our customers while accelerating their path to commercialization.
End-to-End Sterile Manufacturing Flow
One facility · One quality system · One design history file
Whether you're taking a concept to 510(k) clearance, scaling a cleared design, or sourcing from our proprietary portfolio — Ranfac's platform adapts to your program.
Ranfac owns the entire development cycle: DFM, process validation, regulatory submissions (510(k) support, EU MDR technical files), and scaled production under your brand. Complete design history file management from day one.
You bring the design, we bring production muscle. Seamless integration into your existing quality system or extension of ours. High-volume, validated manufacturing with full traceability and real-time ERP visibility.
Ranfac designs and manufactures its own portfolio of minimally invasive, hypodermic-based devices for surgical and interventional applications. Available for distribution or direct purchase.
We specialize deeply — which means we're the best fit for specific program types. Here's how to know if Ranfac is your partner.
Ranfac's platform supports device programs across five core clinical markets — each requiring the precision and sterility our vertically integrated facility delivers.
Trocars, access sheaths, and port systems for minimally invasive surgical procedures. Precision machining meets tight tolerance requirements for safe tissue access.
Bone marrow access needles, aspiration systems, and core biopsy devices. Ranfac's heritage product category with proven designs and validated manufacturing processes.
Cannula and delivery systems for bone graft substitutes, PRP, and regenerative therapies. Custom tip geometries and optimized flow characteristics.
Introducer sets, drainage catheter components, and access needles for image-guided procedures. Tight tolerance manufacturing for critical clinical performance.
Blood collection and processing devices for clinical and laboratory use. Ranfac's proprietary product line serving hematology applications worldwide.
Single-use hypodermic-based instruments for procedural applications. Designed for consistency, safety, and cost-effective single-use performance.
Ranfac helped a leading virtual medical device development company overcome product design challenges to custom-manufacture and launch a transformative women's health device that rapidly penetrated global markets.
40,000 sq. ft. of vertically integrated manufacturing — from raw metal to sterile finished device.
"Without Ranfac, I would have failed. Their deep experience in this field was a really important reason to go for Ranfac. They really stuck with us and were incredibly resilient."
"Ranfac has supplied my company for over twenty years. When I chose Ranfac as our primary supplier, it was one of the best business decisions that I ever made."
"When BONESUPPORT was looking for a precise, cost-effective solution, Ranfac made it simple. Thanks to their attention to detail and creative approach, they've helped us meet customer needs."
Ship to the US, EU, UK, Canada, Japan, Australia, and Brazil from a single qualified facility. MDSAP alone gives simultaneous market access to 5 jurisdictions — no additional certifications needed to enter new markets.
Global quality management standard for medical devices
One audit covers US, Canada, Brazil, Japan, Australia
CE-marked access to 27 European markets
21 CFR 820 (CGMP/QSR) — devices & drug/device combos
Certificate for Free Sale — medical devices
Certificate for Free Sale — biologics & HCTP
Single-facility Avon, MA — no tariff or reshoring risk
20+ concurrent programs, fast changeovers, low MOQ entry
Whether it needs development, production, or both — we'll show you how Ranfac's single-source platform can get it to market faster.