# Scilife launches a Design and Development module for medical devices

Source: https://bestqmssoftware.com/news/scilife-launches-design-and-development/
By Tom Muller, updated October 5, 2026


Scilife announced a Design and Development solution for medical device companies on 15 July 2025.[^ddpress] Its help centre lists version 1.0.0 in July 2025.[^ddnotes] The module holds user needs, design inputs, design outputs, verification, validation and verification and validation runs.[^prefixes]

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).[^ddnotes][^import] On the medical device pricing page, Design and Development is included from the Essential tier.[^mdpricing]

In the launch announcement, Scilife named a regulatory submission workflow and "built-in automated risk management" as upcoming releases.[^ddpress] Today the risk module supports only FMEA, and the design module has no risk item type.[^fmea][^prefixes]

## What it means for buyers

Our [Scilife review](/reviews/scilife/) covers the module and its main gap for device teams: risk assessments aren't linked to design controls.

[^ddpress]: [Scilife: Design and Development solution for medical devices](https://www.scilife.io/press-releases/design-and-development-solution-medical-devices). Vendor press release, 15 Jul 2025, checked 30 Sep 2026.
[^ddnotes]: [Scilife Help Center: Design & Development](https://support.scilife.io/hc/en-us/articles/21053066032668-Design-Development). Vendor help centre release notes, checked 30 Sep 2026.
[^prefixes]: [Scilife Help Center: Prefixes in the Design & Development tool](https://support.scilife.io/hc/en-us/articles/21076813667740-What-prefixes-are-used-in-the-Design-Development-tool). Vendor help centre, checked 30 Sep 2026.
[^import]: [Scilife Help Center: Project import from Excel](https://support.scilife.io/hc/en-us/articles/26914407187484-Project-Import-from-Excel). Vendor help centre, checked 30 Sep 2026.
[^mdpricing]: [Scilife: Pricing for medical devices](https://www.scilife.io/pricing-qms-for-medical-device). Vendor pricing page, checked 30 Sep 2026.
[^fmea]: [Scilife Help Center: What risk assessment methodologies are available?](https://support.scilife.io/hc/en-us/articles/9309343758876-What-Risk-Assessment-Methodologies-are-available). Vendor help centre, checked 30 Sep 2026.