BISC provides a regulatory intelligence platform for medtech and life‑sciences companies, streamlining US FDA compliance and post‑market surveillance. By combining advanced technology with expert regulatory professionals, the platform automates documentation and research while keeping critical decision‑making with humans, enabling significantly faster submission cycles. This approach helps developers bring medical devices and treatments to market more efficiently without compromising safety or quality.
Funding
Funding not disclosed
Founders
Product
Problem
Medtech and life‑sciences companies face lengthy, manual regulatory processes for FDA compliance and post‑market surveillance, which delay product launches and increase resource costs while maintaining safety and quality requirements.
Solution
BISC offers a regulatory intelligence platform that blends automation with expert oversight to streamline FDA submission preparation and ongoing compliance monitoring. The system automates the collection, organization, and analysis of regulatory documentation and research data, reducing manual effort and turnaround time. Expert regulatory professionals remain in control of critical decisions, ensuring that accelerated workflows do not compromise safety or quality. By providing a continuously updated knowledge base and real‑time alerts, BISC enables companies to maintain compliance throughout the product lifecycle and bring devices and treatments to market more efficiently.
Target Audience
Primary users are regulatory affairs teams within medical device manufacturers, biotech firms, and pharmaceutical companies that need to accelerate FDA submissions and maintain ongoing compliance.
Features
- Automated extraction and structuring of FDA-relevant data from diverse sources
- Integrated research tools that generate up-to-date regulatory intelligence reports
- Workflow management dashboards that track submission milestones and post‑market obligations
- Role‑based access controls allowing expert reviewers to approve and edit automated outputs
- Real‑time compliance alerts tied to regulatory changes and post‑market surveillance requirements
- Secure cloud hosting with audit trails to support documentation integrity and traceability