Remedical offers CURA™, a modular SaaS platform that centralizes MedTech regulatory compliance tasks such as complaint handling, adverse event reporting, post‑market surveillance and vigilance. By automating workflows and embedding MDR, FDA and ISO 13485 requirements, the platform reduces manual effort, lowers compliance risk, and provides real‑time audit‑ready documentation for quality and regulatory teams.
Funding
Funding not disclosed
Founders
Product
Problem
MedTech companies often manage regulatory compliance through fragmented processes, manual documentation, and inefficient collaboration, leading to high compliance risk, costly delays, and difficulty maintaining audit readiness.
Solution
CURA™ is a modular SaaS platform that centralizes complaint handling, adverse event reporting, post‑market surveillance (PMS) trending, and vigilance into a single, audit‑ready system. The platform automates regulatory workflows and embeds MDR, FDA, and ISO 13485 requirements, reducing manual effort and minimizing errors. Real‑time traceability links development through post‑market activities, enabling teams to work from a single source of truth. Automated alerts and reporting keep organizations audit‑ready at any time, while collaborative tools streamline communication across quality, regulatory, product development, and clinical teams.
Target Audience
Primary users are quality managers, regulatory affairs professionals, product development engineers, and clinical/post‑market teams within MedTech companies that must meet global regulatory standards.
Features
- End‑to‑end traceability from product development to post‑market activities within one unified interface
- Built‑in compliance checks for MDR, FDA, and ISO 13485 standards
- Automated workflow engine for complaint handling, adverse event reporting, and PMS trending
- Real‑time surveillance dashboards and reporting for clinical and post‑market teams
- Centralized document repository with version control and audit‑ready export capabilities
- Collaborative workspace providing a single source of truth for all compliance stakeholders