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Capability

ISO 13485 certified manufacturing

Suppliers
5
States & provinces
3
Countries
1

5 iso 13485 certified manufacturing suppliers across 3 states and provinces in 1 country. Profiles show capabilities, materials, certifications, and facility locations so you can compare shops and build a shortlist.

Suppliers

ACTIVE LIFE SCIENTIFIC INC

SANTA BARBARA, CA

Active Life Scientific, Inc. is an ISO 13485 certified, FDA-registered manufacturer based in Santa Barbara, California. It makes OsteoProbe®, an FDA-cleared handheld device that measures bone material strength via microindentation on the tibia, reported as the Bone Material Strength Index (BMSi) and BoneScore®. The company was spun out of UC Santa Barbara in 2007 and its device was cleared by FDA in 2021.

bone microindentation measurementFDA-registered manufacturingmedical device manufacturing

ARTISAN POWER LLC

NATICK, MA

Artisan Power is a Massachusetts-based manufacturer of replacement battery packs and accessories for medical devices, wireless phones, two-way radios, barcode scanners and mobile printers, and electric clippers. Founded in 2004, it is ISO 13485 certified, holds a GSA contract, and serves hospitals, retailers, logistics providers, airlines, and government agencies. It stocks thousands of products in its Natick, MA warehouse and offers a 12-month warranty.

battery manufacturingbattery pack designwarehousing and fulfillment

AXIOM TECHNOLOGY, INC. U.S.A.

CITY OF INDUSTRY, CA

Axiomtek is an industrial PC field expert that designs and manufactures embedded computers, Box PCs, industrial motherboards, single board computers, system on modules, touch panel PCs, Ethernet switches, network security appliances and digital signage. The company states over 35 years of experience, 60+ countries covered, 950+ employees worldwide and 450+ global partners, and offers ISO 13485-certified manufacturing for medical-grade embedded systems and panel PCs.

design and manufacturing of embedded computersedge AI solutionsindustrial automation solutionsIT/OT network securitymedical design-intransportation computing solutions

BENDBIO INC

SHARON, MA

BendBio provides the core inertial microfluidics engine for next-generation cell therapy manufacturing systems. Its integration-ready modules for sorting, washing, concentration, and filtration replace legacy platforms like centrifugation, delivering consistent, high-quality output from variable biological inputs. The platform, originally developed at Massachusetts General Hospital, is label-free, gentle, and reagent-free, scaling from milliliters to liters per hour.

cell concentrationcell sortingcell washingfiltrationinertial microfluidicsOEM integration

INFINEUM MEDICAL

LARGO, FL

Infinium Medical, Inc. is a USA manufacturer of patient monitoring systems and critical care equipment, headquartered in Largo, Florida. Its monitors are manufactured at an FDA registered, ISO 13485 certified facility, and the Omni and Cleo lines carry EU MDR and CE certification. The company supplies medical equipment for outpatient centers, hospitals, and clinics, with 500+ equipment SKUs and distribution to 87 countries.

after-sales and warranty servicecentral station network monitoringFDA registered facilityHL7 compliant connectivitymedical device manufacturingparts and repairs

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