Our BrightInsight Platform is built under a Quality Management System to support and optimize up to Class III regulated drugs, devices, software, connected surgical equipment and Digital Therapeutics through integrated data and actionable insights
Hit the ground running with our managed service model, modular platform architecture and foundational capabilities.
Our integrated data management transforms drug and device data into powerful real-time insights.
Our advanced quality, security, privacy and compliance processes and tools give you peace of mind.
Financing led by Insight Partners, the premier global investor in scaling enterprise software companies, with participation from Series A investors, New Leaf Venture Partners and Eclipse Ventures.
Learn MoreCSL Behring selects the BrightInsight Platform to build and manage its digital health solutions within a regulatory-compliant environment.
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If your platform solution does anything beyond transferring, storing, converting the format or displaying medical device data – the definition of a Medical Device Data System (MDDS) – the chances are high that some aspect of a biopharma’s software will be regulated. If you want to manage risk, you need to adopt a more conservative point of view to future-proof your business.
- Bradley Merrill Thompson, Epstein Becker & Green, P.C.
Key considerations and recommendations for successfully navigating cybersecurity regulations and global privacy laws
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