EmpowerReg provides an AI‑native compliance platform (CMPMS™) that unifies post‑market surveillance for medical device and health‑tech companies, automating data intake, complaint triage, risk harmonization, and regulatory reporting. By consolidating public and private signals into a dynamic product‑centric risk profile and offering real‑time dashboards, it enables regulatory and quality teams to proactively manage risk and reduce manual effort across global compliance frameworks.
Funding
Funding not disclosed
Founders
Product
Problem
Regulatory and quality teams in medical device and health‑tech companies must handle large volumes of post‑market data—complaints, adverse events, user feedback, and clinical results—across multiple jurisdictions. Legacy tools are fragmented, require manual triage, and lack integrated risk intelligence, leading to delayed insights, higher operational costs, and increased risk of non‑compliance.
Solution
EmpowerReg offers an AI‑native compliance platform (CMPMS™) that unifies the entire post‑market surveillance workflow from data intake to reporting. The system automatically ingests public and private signals, applies generative AI for complaint triage, risk harmonization, and classification, and continuously updates a dynamic product risk profile. Integrated analytics provide real‑time risk intelligence and regulatory intelligence aligned with FDA, EU, and emerging market standards. Users access a single, regulation‑aware interface that automates routine tasks, reduces manual effort, and enables proactive risk mitigation throughout the product lifecycle.
Target Audience
Primary customers are regulatory affairs, quality assurance, and post‑market surveillance teams at medical device and health‑technology manufacturers, especially small to mid‑size firms seeking to streamline compliance.
Features
- AI‑driven automated triage and classification of complaints, adverse events, and user feedback
- Unified data hub that consolidates public sources, internal reports, and clinical results into a single product‑centric view
- Continuous risk harmonization and dynamic risk profiling across global regulatory frameworks
- End‑to‑end workflow automation from intake, investigation, to regulatory reporting and submission
- Scalable SaaS architecture with built‑in compliance updates for U.S., EU, and emerging market regulations
- Real‑time dashboards and alerts for proactive risk management and operational efficiency