Matrix Quality

eQMS for medical device and life science teams: CAPA, documents, training, suppliers

Quick Overview

Company Matrix Requirements GmbH (HRB Freiburg i. Br. 712907, VAT DE299450873)
Category Quality Management Software
Headquarters Kehl, Germany
EU Presence EU (Germany)
Open Source No
Compliance Vendor states 21 CFR Part 11 and EU Annex 11 support; no ISO/SOC certificate verified
Pricing Pricing on request (site offers 'Get Pricing' and 'Get a Demo'); no public price list.
Free Option Demo on request
Replaces MasterControl, Veeva QMS, Qualio

Detailed Review

Matrix Quality is the eQMS of the Matrix One group, which also sells Matrix Req for design control, Matrix eIFU and Matrix Validate. It targets medical device and life science companies that have outgrown Word, Excel and SharePoint, with teams the vendor puts at 20 to 1,000 people.

It covers quality events and CAPA, document control, training and supplier management in one validated system, with 21 CFR Part 11 and EU Annex 11 electronic signatures and an audit trail on each record. The vendor says more than 50 modules can be configured without code.

Compared with generalists such as ConSense or isoTracker it is built for regulated product teams, and pricing is on request only. The group structure is less simple than a single German company: the legal notice names several entities, and the operator of this product is not stated, so check the contracting party before signing.

What Matrix Quality does well

  • Built for medical device and life science compliance
  • Electronic signatures aligned with 21 CFR Part 11 and EU Annex 11
  • Quality events, CAPA, documents, training and suppliers in one system
  • Same group offers design control and eIFU for medtech
  • Operated by a German GmbH per the legal notice

Where Matrix Quality falls short

  • No public pricing
  • Group spans German, Swiss and US entities
  • Heavier than needed for non-regulated ISO 9001 users
  • Data hosting region not stated

Standout feature. A validated eQMS aimed at medtech that links with design control in the same group's tools.

Pros and Cons

Pros

  • Built for medical device and life science compliance
  • Electronic signatures aligned with 21 CFR Part 11 and EU Annex 11
  • Quality events, CAPA, documents, training and suppliers in one system
  • Same group offers design control and eIFU for medtech
  • Operated by a German GmbH per the legal notice

Cons

  • No public pricing
  • Group spans German, Swiss and US entities
  • Heavier than needed for non-regulated ISO 9001 users
  • Data hosting region not stated

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Frequently Asked Questions

What is Matrix Quality?

Matrix Quality is the eQMS of the Matrix One group, which also sells Matrix Req for design control, Matrix eIFU and Matrix Validate. It targets medical device and life science companies that have outgrown Word, Excel and SharePoint, with teams the vendor puts at 20 to 1,000 people.

Where is Matrix Quality based?

Matrix Quality operates from Kehl, Germany, which places it under EU (Germany). Compliance: Vendor states 21 CFR Part 11 and EU Annex 11 support; no ISO/SOC certificate verified.

What does Matrix Quality cost?

Pricing on request (site offers 'Get Pricing' and 'Get a Demo'); no public price list.. Demo on request.

Who is Matrix Quality best for?

Growing medtech and life science teams leaving spreadsheets. A validated eQMS aimed at medtech that links with design control in the same group's tools.

What are the drawbacks of Matrix Quality?

No public pricing. Group spans German, Swiss and US entities. Heavier than needed for non-regulated ISO 9001 users. Data hosting region not stated.

Is Matrix Quality a good alternative to MasterControl?

Matrix Quality is built as a European alternative to MasterControl: eQMS for medical device and life science teams: CAPA, documents, training, suppliers. It will not be a like-for-like feature match in every respect, so check the review above for where the two genuinely differ before switching.

How does Matrix Quality compare to other Quality Management Software?

Matrix Quality is one of several European Quality Management Software we cover. It is most often compared with MasterControl, Veeva QMS, Qualio.

About the author

Every tool page on European Purpose is researched and drafted with AI assistance, with the compliance and pricing claims checked against the vendor's own documentation, and is published under the editorial responsibility of its founder.

Sebastiaan Smits

Sebastiaan Smits

Founder · Amsterdam, Netherlands

Founder of European Purpose. Researches and writes the reviews and checks where each company is actually established.

Read our editorial process for how we source, verify and update these pages, and how paid visibility works.

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