Compliance automation

Aligned Elements

Evidence strength: Moderate 2 cited · 0 analyst How this is scored

Medical-device ALM and eQMS for design-control and technical-file work. Homepage names pre-defined IEC 62304 Design Control templates. Regulatory-compliance page names IEC 62304-1:2015 software safety classification. Not an FDA PCCP product.

Certification evidence

2 cited mappings · 0 analyst assessments across 1 framework. Counts are public. Requirement labels and quotes stay on Pro.

IEC 62304 · 2 cited

Certification relevance. Cited pages map this listing to IEC 62304 (2 requirements).

Cited page: Aligned: Aligned eQMS and Aligned Elements ALM — a named IEC 62304 requirement.

Cited page · The quoted wording is Pro.

Listing detail and source evidence (Pro)

Included on Pro, Team and Enterprise. Public summaries, tags and official links on this page stay free.

See plans · Sign in

Cited mappings (Pro)

Included on Pro, Team and Enterprise. Public summaries, tags and official links on this page stay free.

See plans · Sign in

Procurement evidence pack (Pro) — print cited mappings and analyst notes. The print view is not on this page.

Vendor / publisher

Aligned AG

Type

Commercial

Official site

https://aligned.ch/

Industries

Medical devices

Frameworks named on cited source

IEC 62304

Last verified

15 October 2026

Listing is not an endorsement, certification or recommendation. Capabilities, availability and framework support can change. Confirm with the vendor and the relevant authority. See the disclaimer.