Scilife launches a Design and Development module for medical devices

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Scilife announced a Design and Development solution for medical device companies on 15 July 2025.1 Its help centre lists version 1.0.0 in July 2025.2 The module holds user needs, design inputs, design outputs, verification, validation and verification and validation runs.3

Later releases added a traceability matrix and DOCX or PDF report exports (October 2025), file uploads (December 2025) and import of whole projects from Excel (March 2026).24 On the medical device pricing page, Design and Development is included from the Essential tier.5

In the launch announcement, Scilife named a regulatory submission workflow and “built-in automated risk management” as upcoming releases.1 Today the risk module supports only FMEA, and the design module has no risk item type.63

What it means for buyers

Our Scilife review covers the module and its main gap for device teams: risk assessments aren’t linked to design controls.

  1. Scilife: Design and Development solution for medical devices. Vendor press release, 15 Jul 2025, checked 30 Sep 2026. ↩︎ ↩︎

  2. Scilife Help Center: Design & Development. Vendor help centre release notes, checked 30 Sep 2026. ↩︎ ↩︎

  3. Scilife Help Center: Prefixes in the Design & Development tool. Vendor help centre, checked 30 Sep 2026. ↩︎ ↩︎

  4. Scilife Help Center: Project import from Excel. Vendor help centre, checked 30 Sep 2026. ↩︎

  5. Scilife: Pricing for medical devices. Vendor pricing page, checked 30 Sep 2026. ↩︎

  6. Scilife Help Center: What risk assessment methodologies are available?. Vendor help centre, checked 30 Sep 2026. ↩︎