QARAlink provides a cloud‑based platform that converts complex medical device and in‑vitro diagnostic regulations into clear, actionable workflows for quality assurance and regulatory affairs teams. The solution offers real‑time regulatory updates, configurable workflow automation, and ISO 27001‑certified data security, helping companies reduce compliance time and cost while accelerating product market entry.
Funding
$936K raised to dateRaised to date based on public sources. This may differ from the amount the company actually raised and is based only on what is publicly available on the internet.
Founders
Product
Problem
Medical device and in‑vitro diagnostic companies must navigate a constantly evolving set of regulations (e.g., MDR, IVDR, MDSAP, FDA, AI‑related rules), which often require extensive documentation, cross‑functional coordination, and frequent updates, slowing product launch and increasing compliance costs.
Solution
QARAlink offers a cloud‑based platform that translates complex regulatory requirements into clear, actionable guidance for quality assurance and regulatory affairs teams. The system provides step‑by‑step workflows, real‑time updates on rule changes, and customizable tools that integrate with existing processes, allowing users to track compliance status across products and regions. Built on ISO 27001‑certified infrastructure, the platform secures sensitive data while delivering transparent audit trails. By centralizing regulatory information and automating routine tasks, QARAlink reduces the time and expense needed to prepare submissions, enabling faster market entry and more efficient scaling of product portfolios.
Target Audience
Primary customers are regulatory affairs and quality assurance teams within medical device, in‑vitro diagnostic, and health‑tech companies that need to manage compliance across multiple product lines and global markets.
Features
- Interactive digital guide that maps specific regulations (MDR, IVDR, MDSAP, FDA, AI) to required documentation and activities
- Real‑time regulatory change notifications with impact analysis for affected products
- Configurable workflow engine that connects QA and RA tasks, tracks progress, and generates audit‑ready reports
- ISO 27001‑compliant data security and role‑based access controls to protect confidential information
- Dashboard with actionable insights, compliance scores, and customizable KPIs for cross‑functional visibility