Medical device and diagnostic industry

Yes. Scilife is aligned with ISO 13485, MDR, IVDR, and FDA QMSR expectations. The platform supports controlled documentation, version control, audit trails, and secure electronic signatures, helping MedTech and diagnostics teams maintain traceability and submission readiness throughout product development.

Scilife helps MedTech teams document and manage design control requirements by centralizing design documentation, maintaining traceability, controlling changes, and supporting approval workflows. This ensures design development files remain complete, consistent, and audit-ready as products move toward regulatory submission.

Design control traceability links user needs, design inputs, outputs, verifications, and validations in a structured, auditable way. Without traceability, MedTech teams may face submission delays, audit findings, or regulatory pushback when evidence is incomplete or inconsistent.

Under MDR and IVDR, regulators expect stronger evidence that compliance is addressed throughout development, not just at submission. This includes clear documentation, controlled changes, and traceable design decisions. Building compliant documentation early helps teams meet these expectations without last-minute remediation.

Yes. In fact, with the right system in place, early compliance and traceability speeds development and innovation as delays and rework are reduced. By building compliant documentation and traceability early, small and mid-sized MedTech teams reduce rework, avoid late-stage surprises, and keep product development moving efficiently.

Rework often happens when documentation gaps are discovered late in development. Scilife helps teams reduce rework by maintaining structured, traceable design documentation throughout development, making it easier to prepare submission-ready records without rebuilding information under pressure.

Yes. Scilife is designed to support European MedTech and diagnostics companies preparing for MDR and IVDR compliance, especially small to mid-sized teams. Its guided onboarding and structured workflows help teams scale compliance as products mature and regulatory expectations increase.

Scilife supports audits and reviews by providing controlled documentation, version history, audit trails, and traceability across design of medical devices and quality records. This allows teams to retrieve evidence efficiently and respond confidently to auditor and regulator questions.

If documentation and change history are unclear post-launch, investigations and corrective actions become more complex and resource-intensive. Maintaining clear, traceable records throughout development helps MedTech teams respond more effectively to post-market issues and regulatory inquiries.

Scilife provides a guided, low-risk onboarding process tailored to MedTech teams. Most customers are able to configure core workflows and start using the platform within weeks, with full onboarding typically completed within 90 days depending on scope.

Yes. Scilife is designed to scale with product maturity, allowing teams to start with core documentation and traceability needs and expand as regulatory requirements increase — without needing to rebuild or replace systems later.

Medical device companies need to implement ISO 13485 when they are involved in one or more stages of the medical device life-cycle and need to demonstrate their ability to consistently meet both customer and applicable regulatory requirements. Under MDR and IVDR, regulators and Notified Bodies expect evidence that quality and regulatory requirements were considered throughout the product lifecycle, not introduced just before submission. If quality processes are only implemented late, teams often struggle to reconstruct design decisions, traceability, and change history.

In early product development for medical technology, spreadsheets and shared drives can help teams move quickly. However, as regulatory expectations increase, these tools often become difficult to control and scale. Spreadsheets and file repositories typically lack structured traceability, controlled change history, and clear approval workflows. As a result, teams may struggle to demonstrate how requirements, design changes, and approvals are linked over time. MedTech teams should transition to a structured QMS when documentation volume grows or when submission timelines approach, to avoid late-stage remediation and rework.