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777 Sourcing.

Capability

ISO 13485

Suppliers
2
States & provinces
2
Countries
1

2 iso 13485 suppliers across 2 states and provinces in 1 country. Profiles show capabilities, materials, certifications, and facility locations so you can compare shops and build a shortlist.

Suppliers

BOUDICCA DX, LLC

BRENTWOOD, TN

Boudicca® DX is a transatlantic precision medicine consulting and CRO firm with business operations legally established in the EU and US (Brentwood, Tennessee, US and Dublin, Ireland, EU). Founded by Dr. Kelly Gordon, it provides regulatory strategy and full-service CRO support for precision medicine tests, medical devices, and targeted therapies across the EU, US, and Rest of World, with 10+ years in business and 169 clients.

AI-assisted regulatory intelligenceclinical biomarker strategycompanion diagnostics developmentIVD developmentLDT developmentQMSR complianceregulatory strategyregulatory submissionsreimbursement and market accessSaMD development

Compiled from public sources

HUMAN BIOSCIENCES INC

GAITHERSBURG, MD

Human BioSciences (HBS) is a wound care manufacturer founded in 1989 by Dr. Manoj K Jain in Kansas. The company pioneered the advanced wound care industry with its proprietary Kollagen technology, the world's first collagen wound care dressings cleared by the FDA in 1991. HBS manufactures FDA-cleared collagen particles, gels, sheets and powders, and supplies hospitals, distributors and OEM partners worldwide.

510(k) and PMA medical devicescollagen processingcontract manufacturingcustom packagingFDA CGMP manufacturing

Compiled from public sources

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