Qity provides a proprietary integrated Quality Management System (iQMS) that streamlines quality management and regulatory processes for medical device development. The platform reduces the regulatory burden on healthcare companies, enabling them to meet quality objectives and accelerate the market entry of their products.
Funding
Funding not disclosed
Founders
Product
Problem
Medical device development is subject to stringent quality management and regulatory requirements, creating a significant administrative burden for companies. Navigating complex regulations and maintaining comprehensive documentation can be time-consuming and costly, potentially delaying product launches.
Solution
Qity offers an integrated Quality Management System (iQMS) designed to streamline quality management and regulatory processes specifically for medical device development. The platform provides a centralized system for managing documentation, tracking compliance requirements, and automating workflows. By consolidating these processes, Qity aims to reduce the regulatory burden on healthcare companies, enabling them to efficiently meet quality objectives and accelerate the market entry of their products. The iQMS helps ensure adherence to industry standards and simplifies audits, ultimately improving overall efficiency and reducing the risk of non-compliance.
Target Audience
Qity's primary customers are medical device manufacturers, including startups and established companies, seeking to streamline their quality management processes and ensure regulatory compliance.
Features
- Centralized document management with version control and audit trails
- Automated workflow management for tasks such as CAPA (Corrective and Preventive Action) and change control
- Integrated risk management tools for identifying and mitigating potential hazards
- Compliance tracking with real-time updates on regulatory requirements
- Electronic signature capabilities for secure and compliant approvals
- Customizable dashboards and reporting for monitoring key performance indicators (KPIs)