FDA submission support

BCA Services LLC is a consulting firm serving federal, health, and life sciences missions. It combines talent and technology to solve organizational challenges, offering AI support and training, training and development, business and program management, records and information management, life sciences and clinical research support, and healthcare support services. It holds SBA 8(a), HUBZone, WOSB, ISO/IEC 27001:2013, and ISO/IEC 20000-1:2018 certifications.

AI assessment and roadmap developmentAI-powered search enginesBiostatistical analysiscurriculum developmentdigital document conversionEHR optimizationFISMA compliance supportHIPAA compliance & risk managementinstructional design & eLearningpreclinical & laboratory studiesprocess optimizationproject portfolio managementprotocol development & reviewretention policy developmentsite management & monitoringStrategic Planning & Executiontraining delivery & facilitation

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 developmentIEC 62304 lifecycle processesISO 13485 documentationmobile app developmentPCB designpenetration testingrapid prototypingrisk managementSBOM generationthreat modelingUsability engineeringWi-Fiwireless systems design

Freelong Health, LLC provides compliance tools and expert advisory services for regulated digital health and medical device software development, integrating regulatory architecture with validation engineering. Its offerings cover ISO 13485 QMS, IEC 62304 lifecycle controls, ISO 14971 risk management, FDA cybersecurity compliance, and AI/ML validation strategy.

AI/ML validationautomation-driven continuous validationcybersecurity compliance reviewDHF remediationQMS developmentRegulatory consultingrisk-based verification and validationtest harness engineering