ReviewsSimplerQMS

SimplerQMS review

A validated, document-centred eQMS for small and mid-sized life-science companies, with implementation, validation and training in one published starting price. Design controls, risk and software work are handled as documents rather than linked items.

Price
from $17.5k/yrMinimum $17,500 a year covers up to 15 users
Free trial
Free trialGuided trial after a call; interactive tours
EU hosting
EU or US, selectablePublic DPA; no current subprocessor list
Last checked
Oct 2026
Placeholder data: some scores, prices and features on this page have not been verified yet.

What we like

  • Published starting price: $17,500 a year for up to 15 users, with implementation, validation, data migration and unlimited training included.
  • Customer service is rated 4.9/5 on Capterra (36 reviews, Sep 2026), and reviewers repeatedly praise onboarding.
  • Documents are written in Word, Excel and PowerPoint, while reviews, approvals and e-signatures run in SimplerQMS.
  • A public help center documents the document control, change control, training, quality event and CAPA workflows step by step.
  • ISO 13485 and ISO 27001 certified vendor, with IQ/OQ/PQ documentation and a choice of US or EU hosting.

What to watch

  • Design controls, risk management and software lifecycle are handled as documents, with no native links between requirements, risks and tests.
  • Supplier qualification and audit planning are described only on marketing pages and in older release notes.
  • Reviewers report a dated or unintuitive interface, occasional slowness, and a weaker experience on Mac than on Windows.
  • Standard terms auto-renew the contract unless you cancel in writing 90 days ahead, and raise prices 5% every January.
  • Requires Microsoft 365 licences, and vigilance reports are filed outside the system.

About the price: Vendor-published Starter price for up to 15 users (Sep 2026), including implementation, validation, migration and training. Per-licence prices not published; standard terms add 5% a year.

What is SimplerQMS?

SimplerQMS is an electronic QMS from SimplerQMS A/S, a Copenhagen company founded in 2017 by two former Ambu employees.12 It sells to life-science companies in general: medical devices, pharma and biotech, laboratories and CROs.3 Device makers make up most of its named customers and Capterra reviewers.34

The product began as a configured version of the M-Files document management platform, hosted on Microsoft Azure.56 That M-Files-based version 3.x still receives validated releases (3.6.1 in September 2026).7 Since December 2025, a newer web application has had its own help center and release notes. The vendor’s current pages describe hosting on AWS.8910 SimplerQMS doesn’t say which version new customers get, so ask during the demo.

Who SimplerQMS is for

It fits small and mid-sized device or pharma companies that:

  • already write procedures in Microsoft Word;
  • want the vendor to handle setup, validation and migration;
  • mostly need document control, training, change control and CAPA.

The Starter plan covers up to 15 users, and all services are bundled into the subscription.10 Reviewers include five-person MDR startups as well as pharma QA teams.4

Look elsewhere if you:

  • Build software or complex devices. Design control and risk are document collections and templates.1112 The only IEC 62304 statement is a generic claim of “alignment”.13 A consultant on Reddit found it well designed “maybe not for highly-complex, software-heavy devices”.14
  • Are a team of two or three. The $17,500 minimum is steep at that size.10
  • Use Google Workspace for documents. Editing runs through Microsoft 365, and the vendor lists the need for Microsoft 365 licences as a drawback.1516

SimplerQMS pricing

SimplerQMS publishes a starting price (checked 30 September 2026):10

  • Starter: “Starting from USD 17,500 annually” for up to 15 users. This is also the minimum subscription.
  • Team & Enterprise: more than 15 users, quote only.
  • Licences: Viewer (free, read-only), Light, Standard and Full. Their prices aren’t published, and the exact price comes in a sales meeting.

The subscription includes implementation, IQ/OQ/PQ validation, data migration, unlimited live training, QMS templates, hosting and 24/7 emergency phone support, with no onboarding fee.10 A 10-person team fits inside Starter, so the entry cost is about $17,500 a year, but the licence mix can raise it.10

The standard terms add 5% to all prices every 1 January and renew the subscription automatically (see buying terms below).2 Licence counts can only be reduced at renewal.10

Features

We checked features against SimplerQMS’s public help center, the older knowledge base and release notes, and product pages.87

Document control and records

Documents are written and edited in Microsoft Word, Excel or PowerPoint and checked back in to SimplerQMS. A Word add-in syncs document properties.1517 The help center documents the route from draft through review and approval to effective, with version compare, full history and an audit trail.1819 Approvals use username-and-password e-signatures.20 Since December 2025, authors can generate an AI summary of changes when sending a document for approval.9

Change control and training

Change requests have planning, execution and closure phases. Admins can configure change types, and mandatory actions and effectiveness checks can be switched on.21 Training rules assign documents to users or groups and create training records automatically. Users acknowledge training with an e-signature.2220 The M-Files-based version documents multiple-choice quizzes.23

CAPA and quality events

Observations, quality events and CAPA share one documented workflow:2425

  • Quality events: complaints, nonconformances and deviations, audit findings and supplier issues are the default event types.26
  • CAPA: has planning and execution phases and an effectiveness check. If the check fails, the CAPA reopens.25
  • Vigilance: event types can require a reportability assessment. The report itself is filed outside SimplerQMS.27

We found no UDI, eMDR or EUDAMED features.

Design controls and risk

The design control module organises documents. Templates and “collections” group the design history file, device master record, device history record and technical file.11 Risk management works the same way. Risk files are controlled documents, and traceability comes from a traceability-matrix document template.12 The vendor says Jira documents can be brought in, but we found no documentation of a Jira integration.11

Supplier and audit management

Product pages describe supplier qualification, approved supplier lists, audit plans and escalating findings to CAPA.2829 The newer help center documents none of these beyond the supplier-issue and audit-finding event types.26 Release notes for the M-Files-based version show that supplier audits exist.7

What users say

  • Capterra: 4.5/5 from 36 reviews, with 4.3/5 for ease of use and 4.9/5 for customer service (checked in a browser, 30 September 2026).4
  • G2: 4.6/5 from 15 reviews, with 8.3/10 for ease of use and 9.4/10 for support.30

All 36 Capterra reviews were read in October 2026: Capterra labels 35 of them as invited by the vendor, and 13 arrived within two weeks in August 2022.4 Because invited and burst reviews tend to skew positive, our usability, support and sentiment scores are capped at 8 rather than taken at face value.

Recurring themes on Capterra:4

  • Support and onboarding get the most praise, including hands-on training and fast answers.
  • Easy to use is a common comment, especially from small device teams moving off paper.
  • Dated interface and cumbersome workflows. Several users report an interface that could be more intuitive and a learning curve.
  • Slowness and platform gaps. Several users report slowness or instability. Mac users report a weaker experience because the M-Files desktop client runs only on Windows.6
  • Renewal dispute. One September 2026 reviewer describes a dispute over renewal and termination.

The vendor itself lists a learning curve and “occasional connection issues or bugs” as drawbacks.16 On Reddit, we found too few independent first-hand comments to judge.1431 A burst of near-identical recommendations in May 2026 looked promotional, so we left it out.

Security, hosting and validation

SimplerQMS A/S states that it is certified to ISO/IEC 27001:2022, and it has held ISO 13485 certification from Bureau Veritas since 2018.1332 We found no SOC 2 report for the vendor itself.13 The vendor says customers can choose US or EU hosting, and new customer accounts are tagged EU or US.1633

The public data processing agreement dates from March 2024.34 It names M-Files and Microsoft Azure and says data stays in the region the customer chooses. It predates the AWS hosting described on current pages, and we found no separate subprocessor list. Validation documentation (plan, report and IQ/OQ/PQ) is included, and each release is revalidated.3210 Single sign-on works with Microsoft Entra ID and Google Workspace.35

Buying and contract terms

  • Trial: the free trial is guided. After you request one, the team discusses your goals and decides whether a trial makes sense.10 The website also has interactive product tours.36
  • Contract: yearly subscription with automatic one-year renewals and a 90-day notice period.2
  • Leaving: when a subscription ends, SimplerQMS exports all content as Excel metadata files plus the documents, available for 15 days.2 The pricing FAQ says this export comes at no additional charge, and the terms only require that all invoices are paid.102 CSV exports are also documented.3738 An API exists, but its documentation isn’t public.15
  • Go-live: the vendor quotes 5–6 weeks, about six weeks or 6–8 weeks, depending on the page. Its implementation page asks a super-user to spend one to two days a week on it.3910
  • Templates: template packages for ISO 13485 and 21 CFR 820 are included.10
  • Price increases: the terms raise all prices by a fixed 5% every 1 January, for existing contracts too.2 The entry price has also risen over time. Archived copies of the pricing page show $1,150 a month for up to 10 users from 2023 to late 2024, and $1,200 a month in 2025.4041 Today it is $17,500 a year for up to 15 users, 27% more than in 2024, though it now covers more users.10 Above 15 users the price is quote-only, so we couldn’t check how cost grows from 10 to 25 users.
  • If the vendor closes or is sold: the terms promise the exit export whenever a subscription ends, but they say nothing specific about insolvency, the service being shut down or a change of owner, and there is no escrow. SimplerQMS may transfer the contract to another company without your consent.2 Data is destroyed 15 days after termination, so plan the export early.2

Company and ownership

SimplerQMS A/S is registered in Denmark under CVR 39039923. It was registered on 27 October 2017 as SimplerProces A/S and renamed SimplerQMS A/S in June 2018.4243 It is privately held. Register entries from January 2025 list three holding companies as shareholders (AMB Holding ApS, Businessystemservices ApS and OV Invest ApS), and the register mirror counts eight shareholders in total.42 A co-founder is CEO.44 We found no acquisition or change of control.

The 2025 annual report, filed in June 2026, shows new equity of DKK 17.5 million raised during the year. Investors aren’t named in the sources we could read.44 It also shows:44

  • Results: gross profit of DKK 3.4 million (2024: 5.8 million) and a loss of DKK 5.7 million (2024: profit of DKK 0.3 million).
  • Balance sheet: equity of DKK 12.4 million at year end.
  • Staff: an average of 15 employees (2024: 9).

Verdict

SimplerQMS scores 7.4. Small and mid-sized device or pharma teams should shortlist it if they want a Word-based, validated QMS set up for them at a published price, with support that users rate highly. Reasons to hesitate are the document-only approach to design controls, risk and software, supplier and audit features that are hard to verify, and renewal terms that need careful reading.

  1. SimplerQMS: About us. Vendor website, checked 30 Sep 2026. ↩︎

  2. SimplerQMS A/S: Terms and conditions. Vendor legal page, last updated 14 Oct 2024, checked 30 Sep 2026. ↩︎ ↩︎ ↩︎ ↩︎ ↩︎ ↩︎ ↩︎ ↩︎

  3. SimplerQMS: Customers and case studies. Vendor website, checked 30 Sep 2026. ↩︎ ↩︎

  4. Capterra: SimplerQMS reviews. Review site, ratings checked in a browser 30 Sep 2026; review-source labels checked 4 Oct 2026. ↩︎ ↩︎ ↩︎ ↩︎ ↩︎

  5. KMWorld: SimplerQMS and M-Files speed go-to-market for life sciences startups. Trade press, 6 Jun 2019. ↩︎

  6. SimplerQMS knowledge base: Working with SimplerQMS / M-Files. Vendor documentation, checked 30 Sep 2026. ↩︎ ↩︎

  7. SimplerQMS knowledge base: Release notes. Vendor release notes (versions 3.x), checked 30 Sep 2026. ↩︎ ↩︎ ↩︎

  8. SimplerQMS Knowledge Base (help center). Vendor documentation, checked 30 Sep 2026. ↩︎ ↩︎

  9. SimplerQMS help: AI, action types filter and saved views. Vendor release notes, App Version 1.1.0, Dec 2025. ↩︎ ↩︎

  10. SimplerQMS: Pricing and licenses. Vendor website, checked 30 Sep 2026. ↩︎ ↩︎ ↩︎ ↩︎ ↩︎ ↩︎ ↩︎ ↩︎ ↩︎ ↩︎ ↩︎ ↩︎ ↩︎

  11. SimplerQMS: Design control software. Vendor website, checked 30 Sep 2026. ↩︎ ↩︎ ↩︎

  12. SimplerQMS: Risk management. Vendor website, checked 30 Sep 2026. ↩︎ ↩︎

  13. SimplerQMS: Homepage. Vendor website, checked 30 Sep 2026. ↩︎ ↩︎ ↩︎

  14. r/MedicalDevices: Anyone using Microsoft Teams for IVD dev eQMS doc control?. Community discussion, Mar 2024. ↩︎ ↩︎

  15. SimplerQMS: Technology platform. Vendor website, checked 30 Sep 2026. ↩︎ ↩︎ ↩︎

  16. SimplerQMS: SimplerQMS vs Qualio. Vendor comparison page (used only for statements about SimplerQMS itself), checked 30 Sep 2026. ↩︎ ↩︎ ↩︎

  17. SimplerQMS help: Using the SimplerQMS Word add-in. Vendor documentation, checked 30 Sep 2026. ↩︎

  18. SimplerQMS help: Understanding the document workflow. Vendor documentation, checked 30 Sep 2026. ↩︎

  19. SimplerQMS help: Reviewing document history. Vendor documentation, checked 30 Sep 2026. ↩︎

  20. SimplerQMS help: Managing your training and learning. Vendor documentation, checked 30 Sep 2026. ↩︎ ↩︎

  21. SimplerQMS help: Understanding the change request workflow. Vendor documentation, checked 30 Sep 2026. ↩︎

  22. SimplerQMS help: Creating a training rule. Vendor documentation, checked 30 Sep 2026. ↩︎

  23. SimplerQMS knowledge base: Creating and managing quiz. Vendor documentation, checked 30 Sep 2026. ↩︎

  24. SimplerQMS help: Events module introduction. Vendor documentation, checked 30 Sep 2026. ↩︎

  25. SimplerQMS help: Understanding the events workflows. Vendor documentation, checked 30 Sep 2026. ↩︎ ↩︎

  26. SimplerQMS help: Events settings. Vendor documentation, checked 30 Sep 2026. ↩︎ ↩︎

  27. SimplerQMS help: Vigilance reporting. Vendor documentation, checked 30 Sep 2026. ↩︎

  28. SimplerQMS: Supplier quality management. Vendor website, checked 30 Sep 2026. ↩︎

  29. SimplerQMS: Audit management. Vendor website, checked 30 Sep 2026. ↩︎

  30. G2: SimplerQMS reviews. Review site, checked in a browser 30 Sep 2026. ↩︎

  31. r/IndustrialMaintenance: What tools or apps are you using to create SOPs?. Community discussion, Jul 2026. ↩︎

  32. SimplerQMS: Certification and regulatory compliance. Vendor website, checked 30 Sep 2026. ↩︎ ↩︎

  33. SimplerQMS help: Consistent document numbering and process owner control. Vendor release notes, Mar 2026. ↩︎

  34. SimplerQMS A/S: Data processing agreement. Vendor legal page, last updated 13 Mar 2024. ↩︎

  35. SimplerQMS help: Setting up Microsoft Entra SSO and Google SSO. Vendor documentation, checked 30 Sep 2026. ↩︎

  36. SimplerQMS: Interactive product tour. Vendor product tour (title checked only), 30 Sep 2026. ↩︎

  37. SimplerQMS knowledge base: Exporting metadata and documents. Vendor documentation, checked 30 Sep 2026. ↩︎

  38. SimplerQMS help: Improve due date management and quality workflows. Vendor release notes, checked 30 Sep 2026. ↩︎

  39. SimplerQMS: Implementation. Vendor website, checked 30 Sep 2026. ↩︎

  40. SimplerQMS pricing page, archived 3 Feb 2024. Vendor website via Wayback Machine, checked 1 Oct 2026. ↩︎

  41. SimplerQMS pricing page, archived 24 Jun 2025. Vendor website via Wayback Machine, checked 1 Oct 2026. ↩︎

  42. North Data: SimplerQMS A/S, Copenhagen. Mirror of the Danish CVR register, checked 1 Oct 2026. ↩︎ ↩︎

  43. Danish Business Authority: filings for CVR 39039923. Company register open data, checked 1 Oct 2026. ↩︎

  44. SimplerQMS A/S: Annual report 2025. Filed accounts (Danish Business Authority), published 27 Jun 2026, checked 1 Oct 2026. ↩︎ ↩︎ ↩︎

Visit the SimplerQMS website (made by SimplerQMS A/S)

Notable features

Built-in document editorNoDocuments are written in Microsoft Office, not in a built-in editor
Edit in Word or Google DocsYesWord, Excel and PowerPoint via Microsoft 365 and a Word add-in; Microsoft 365 licences required
SOP templates includedYesISO 13485 and 21 CFR 820 template packages included
Jira or Git integrationPartly or add-onJira named on marketing pages; no documented integration
IEC 62304 software featuresNot confirmed yetOnly a generic 'supports alignment with IEC 62304' claim
Validation package includedYesValidation plan, report and IQ/OQ/PQ included; revalidated each release
Public APIPartly or add-onAPI stated and API keys in admin settings; no public documentation
Single sign-on (SSO)YesMicrosoft Entra ID and Google Workspace on all licence types
Supplier portalNot confirmed yetNo supplier portal found
Training with quizzesYesMultiple-choice quizzes with a quiz report
FDA MDR or EU vigilance reportingPartly or add-onVigilance reportability assessment; reports filed outside the system
AI featuresYesAI-generated change summaries when sending documents for approval

ISO 13485 clause coverage

ClauseRequirementSimplerQMS
4.2.4Control of documents
4.2.5Control of records
6.2Training and competence
7.3Design and development
7.3.9Change control
7.4Supplier qualification and control
7.5Production records (DMR/DHR)
UDIUDI management (EU MDR, FDA)
8.2.2Complaint handling
8.2.3Regulatory reporting (FDA MDR, EU vigilance)
MDR 83Post-market surveillance
8.2.4Internal audit
8.3Nonconforming product
8.5.2Corrective action (CAPA)
ISO 14971Risk management file
IEC 62304Software lifecycle
Part 11Electronic signatures
Supported out of the boxPartial, or needs an add-onNot supportedNot confirmed yet

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