Beebrox

Beebrox is bridging Regulatory and Quality Consulting of the medical devices industry with work in design and development offering holistic coverage of regulatory requirements driving remediation strategies. The scope of services, guided by respective recognized standards are: - Quality Management System support, - Clinical Evaluation and Performance Evaluation Affairs, - Design controls, verification services, - Biocompatibility and toxicological remediation strategies , - Usability engineering and summative evaluation studies, - Electrical safety pre-testing, planning, and remediation strategies, - Risk Management, data mining services, and literature searches for assigning risk levels, - Usability engineering with formative and summative tests, - Cybersecurity integration into software lifecycle and risk management, - AI/ML integration into software cycle and risk management, From the engineering standpoint, with our partners, we offer solutions in these domains supporting product designs at any stage of the lifecycle: - embedded design and software development, - mechanical design and design for biocompatibility - biocompatibility testing and chemical characterization, Working with sophisticated tools, we can establish physical models and model your design identifying the path to an optimized state. Since 2024, we have been using private computing to take advantage of AI tools and increase competitiveness in processing the workload in a way no confidentiality or privacy is breached.