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ISO 13485 documentation

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

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BOLD TYPE HOLDINGS, LLC

ORLANDO, FL

Bold Type is a U.S.-based, ISO 13485-certified engineering firm that develops FDA-compliant medical device electronics and software. Its integrated team covers embedded firmware, wireless systems, mobile and cloud apps, electronics design, and cybersecurity, supported by medical device veterans, cybersecurity experts, and AI-assisted development. Its CyberMed division provides threat modeling, penetration testing, and post-market cybersecurity management.

antenna designBLEcellular (LTE-M, NB-IoT)cloud infrastructurecybersecurity engineeringElectronics Designembedded software developmentFDA submission supportIEC 62304 lifecycle processesmobile app developmentPCB designpenetration testingrapid prototypingrisk managementSBOM generationthreat modelingUsability engineeringWi-Fiwireless systems design

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