Smart QMS for Medical Devices

Scilife's Smart QMS for Medical Devices is a validated, cloud-based quality management software platform purpose-built for medical device manufacturers and their QA teams. It centralises all quality and design control documentation in one place, enabling organisations to accelerate product development from idea to market while maintaining full traceability and regulatory compliance.

The platform is designed to meet ISO 13485 and FDA 21 CFR Part 820 requirements, helping teams simplify audits, reduce compliance risk, and remain inspection-ready at all times. With 21 CFR Part 11-compliant audit trails and electronic signatures built in, Scilife provides the structured oversight needed for regulated medical device development without manual complexity.

Core Compliance and Quality Capabilities

• Stay compliant with confidence: Built-in support for ISO 13485 and FDA 21 CFR Part 820 requirements simplifies audit preparation and reduces regulatory risk.
• Document control: Manage every document from creation through approval with automation, audit trails, and permission settings tailored for compliance.
• Training and competence management: Ensure teams are always audit-ready with role-based training linked directly to document updates and compliance requirements.
• Quality events and CAPAs: Capture deviations, complaints, and quality events in real time, with thorough documentation and structured corrective and preventive action workflows.
• Change control and supplier management: Manage change requests and supplier qualifications from a single secure platform to ensure ongoing product safety and reliability.

Design Control and Traceability Features

• Design and development tool: Streamline the design process with intuitive workflows, a powerful traceability matrix, and a version comparison tool.
• End-to-end traceability matrix: View, add, update, or remove design controls and verification or validation runs directly from the matrix, ensuring seamless traceability across the product lifecycle.
• Instant audit-ready reports: Generate up-to-date reports in a few clicks for internal reviews, external partners, or regulatory submissions, directly from the project workspace.
• Ready-to-use report templates: Out-of-the-box templates built on industry best practices eliminate the need to manually design or configure reporting formats.

Platform Packages and Modules

• Essential: Includes Design and Development, Document Management, Training Management, Competences, Records, Scilife Academy Access, and KPIs.
• Core: Everything in Essential, plus CAPAs, Change Control, and Quality Events (deviations, non-conformities, complaints, and event management).
• Core+: Everything in Core, plus Audits, Supplier Management, Risk Assessment, and Equipment management.
• Free Trial: A risk-free evaluation environment that includes all Essential and Core features.

Reported Business Outcomes

• Reduce time-to-market by up to 35% through streamlined quality and design control workflows.
• Lower compliance costs by up to 50% by automating manual quality processes and centralising documentation.
• Enables lean QA teams to manage high volumes of compliance work as organisations scale.

Scilife operates with offices in Brussels (EMEA) and New York (US), serving leading medical device organisations globally. The platform is validated for regulated environments and supports the full spectrum of quality system requirements, making it suitable for device manufacturers at any stage of growth.