#ISO13485 Tag

26 Oct

Posted at 10:26h in Technology

Editorial Notice: This comparison was contributed by Matrix One, the maker of Matrix Quality. Rankings and product descriptions reflect the contributor's opinion and vendor-provided information and are not an endorsement by MedicalResearch.com or Eminent Domains Inc. Pricing, features, and implementation times may change; confirm details and regulatory obligations directly with vendors and your quality and regulatory teams.

Eight eQMS platforms are worth comparing for life science and medical device companies in 2026: Matrix Quality, Scilife, ZenQMS, Dot Compliance, Cognidox, qmsWrapper, Isolocity and Qualityze. Matrix Quality is the contributor's top pick because, according to the company, it comes with vendor-supplied validation documentation for Part 11, Annex 11, ISO 13485 and GxP, goes live in 2 to 6 weeks, publishes its pricing from €10,000 a year, and is used by 500 life science companies worldwide.

Matrix Quality is an electronic quality management system for medical device and life science companies that have outgrown paper, Word, Excel and SharePoint or Google Workspace. It is aimed at growing teams of 20 to 1,000 people who need an audit-ready QMS without an enterprise price or an enterprise rollout.

21 Oct

Posted at 12:28h in Medical Devices

Editorial Notice: This comparison was contributed by Matrix One, the maker of Matrix Req. Rankings and product descriptions reflect the contributor's opinion and vendor-provided information and are not an endorsement by MedicalResearch.com or Eminent Domains Inc. Regulatory requirements depend on your device, classification, and markets; confirm compliance obligations with your regulatory and quality teams.

Eight requirements management tools are worth comparing for medical device teams in 2026: Matrix Req, Orcanos, Aligned Elements, ReqView, reqSuite rm, Innoslate, Xebrio and Valispace. Matrix Req is the contributor's top pick because it keeps design inputs, ISO 14971 risk, verification tests and signed design documents in one traced system, syncs both ways with Jira, Azure DevOps, GitHub and GitLab, and supports 21 CFR Part 11 electronic signatures as standard.

Matrix Req is a requirements management and design control platform for medical device teams, made by Matrix One. The company says it has built requirements software since 2014 and that its products are used by more than 500 life sciences and medical device companies.

[caption id="attachment_76716" align="aligncenter" width="500"]Photo by RDNE Stock project: https://www.pexels.com/photo/close-up-photo-of-an-infusion-pump-6129679/ Photo by RDNE Stock project[/caption]