Single-Source Hypodermic Device Manufacturing
We machine the metal, mold the plastic, assemble in our Class 7 clean room, and deliver a sterile finished device — one facility, one quality system, one partner. Precision hypodermic-based devices for any application, manufactured in Avon, MA since 1888.
Precision Hypodermic Device CDMO
11 precision processes, Class 7 & 8 cleanrooms, and an exclusive STERIS EO sterilization partnership. ISO 13485, MDSAP, EU MDR, and FDA registered. 40,000 sq. ft. of vertically integrated capability in Avon, MA.
Company SNAPSHOT
1888
1
40,000
>600,000
One Platform. Three Ways to Partner.
Ranfac’s vertically integrated manufacturing platform covers every step from raw metal and polymer to sterile finished device. Whether you need full development support, production-only scale, or access to our proprietary device portfolio, our 40,000 sq. ft. facility in Avon, MA delivers Class I and II hypodermic devices under one quality system, one roof.
Contract Development & Manufacturing (CDMO)
Contract Manufacturing (CMO / OEM)
Proprietary Devices & Surgical Solutions
Who We Are
Meet the Ranfac team and learn more about our mission to achieve excellence in medical device manufacturing.
Case Study
Learn how Ranfac helped a leading virtual medical device development company overcome product design challenges to custom-manufacture and launch a transformative device that rapidly penetrated global markets.
Testimonials
Regulatory-Ready for Global Markets
Ship to the US, EU, UK, Canada, Japan, Australia, and Brazil from a single qualified facility. Our quality system is audited under five regulatory frameworks simultaneously, so you never wait for additional certifications to enter a new market:
- ISO 13485:2016 — Global quality management standard for medical devices
- MDSAP — One audit covers US, Canada, Brazil, Japan, and Australia
- EU MDR Compliant — CE-marked access to 27 European markets
- FDA 21 CFR 820 (CGMP/QSR) — US current Good Manufacturing Practice
- FDA Registered Facility — Devices and drug/device combinations
- FDA CFG (CDRH) — Certificate for Free Sale, medical devices
- FDA CFG (CBER) — Certificate for Free Sale, biologics and HCTP
Start Your Project
Tell us about your hypodermic device — whether it needs development, production, or both — and we will show you how Ranfac’s single-source platform can get it to market faster.