Scilife alternatives for medical device companies

The best alternatives to Scilife, ranked by overall score.

By · Updated

Scilife is a life-sciences eQMS from Belgium that users find easy to learn, with an included validation package. Its strongest ground is GMP work, and its design controls module is new. Device teams usually start comparing it with other systems for one of the reasons below. This page covers what our evidence shows, which alternatives fit which situation, and when staying put is the better call.

Why teams look for Scilife alternatives

Risk isn’t linked to design. The Design and Development module launched in July 2025.1 The risk module supports only FMEA and targets processes, equipment and systems.23 Risk items don’t exist in the design module.4 Scilife announced built-in risk management for design as upcoming in July 2025.1 To build a design history file, the vendor says you export and compile it yourself.5

Complaints and post-market work. Complaints run through configurable event types shared with deviations and non-conformities.67 We found no reportability decision, no FDA MDR or EU vigilance reporting, and no device history record features.8 UDI is only an optional field on design projects.9

Software development. We found no Jira or Git integration, and IEC 62304 support is only a product-page claim.105

No prices. Scilife doesn’t publish prices, and archived versions back to 2021 never showed them.111213 Licences are per user, and deactivated users still count.14 Audits and supplier management need the top tier, Core +.11 The terms let Scilife change its fees once a year with 60 days’ notice and no cap, and data storage is billed per gigabyte on top.15

Security paperwork. The only certification we found is ISO 9001, with no ISO 27001 or SOC 2 claim.16 We found no public data processing agreement or subprocessor list.17

Which alternative fits your situation

You build devices and want design, risk and complaints linked: Greenlight Guru

Greenlight Guru builds software only for medical device companies.18 Its product tour shows user needs, inputs, outputs, verification and validation linked in one matrix, and trace graphs flag missing links across design, risk and tests.1920 Complaint handling includes a step for deciding whether a regulatory report is needed, which creates a task to prepare the FDA report.21 The vendor states ISO 27001 and SOC 2 certification.1822 eQMS packages start at $12,000 a year, with implementation quoted separately; Vendr reports a median of $43,989 a year.1823 There are no pharma GMP modules, so companies that also make drugs lose what Scilife does best.18

You make devices and drugs and want risk tied to design: Qualio

Qualio runs deviations, OOS and pharmacovigilance in the same platform as its device design controls.24 Design controls support up to three requirement levels with verification and validation test cases, ISO 14971 risk and generated trace matrices.25 Jira is included.26 Its DPA lists ISO 27001 certification, and its public subprocessor list names AWS in Dublin as the web-application host.2728 Like Scilife, Qualio doesn’t publish prices, and every plan carries an implementation fee.26 There’s no free trial, and complaints are only an example template in the configurable Events module.2930

You build software as a medical device: Matrix Requirements or Ketryx

Matrix Requirements documents configurable traceability rules, links issues to Jira, GitHub, GitLab and Azure DevOps, and has an IEC 62304 template package.313233 It publishes prices and offers a self-serve trial.3435 Supplier, audit and nonconformance workflows need a second product, the Salesforce-based Matrix Quality.36

Ketryx syncs requirements, software items, tests and risks from Jira, Git and test tools and generates the design history file from them.37 It holds ISO 27001 and SOC 2 Type 2.38 You can start a 30-day trial without a credit card.39 Paid plans are contact-sales,40 and we found no documented supplier, internal audit or production record workflows.41

You want a published price and a certified vendor: SimplerQMS

SimplerQMS starts at $17,500 a year for up to 15 users, including implementation, validation, data migration and training (Sep 2026).42 Documents are written in Word, Excel or PowerPoint, as with Scilife’s Word editing.43 SimplerQMS states ISO 27001 certification and has held ISO 13485 since 2018.4445 Complaints are a default event type, and event types can require a reportability assessment; the report itself is filed outside the system.4647 Design controls and risk are document collections, not linked records, so this is a step back from Scilife’s design module.4849 Its terms add a fixed 5% to all prices every 1 January.50

When to stay with Scilife

Scilife’s strengths are real, and switching an eQMS takes work:

  • Pharma and devices in one system. Deviations, equipment qualification and controlled printing sit alongside design controls.11
  • Validation included. Customers receive an executed GAMP 5 package with IQ, OQ, PQ and a traceability matrix.51 An updated package arrives 60 days before each medium or major release.52
  • Easy to learn. G2 reviewers rate ease of use 8.6/10 and quality of support 8.9/10 (Sep 2026).53 G2 labels 89% of those reviews as invited by the vendor or incentivized.54
  • Design traceability. The traceability matrix flags unlinked items and exports to DOCX, XLSX, PDF or CSV.55
  • EU hosting. Customers who need GDPR compliance are hosted in Europe.11
  • Clean exit. The terms promise a one-time transfer of all your data at no extra charge.15

If price is the issue, ask for a written quote per tier and a renewal cap in writing.1115

  1. Scilife: Design and Development solution for medical devices. Press release, 15 Jul 2025. ↩︎ ↩︎

  2. Scilife Help Center: What risk assessment methodologies are available?. Vendor help center, checked 30 Sep 2026. ↩︎

  3. Scilife Help Center: Linked vs standalone risk assessments. Vendor help center, checked 30 Sep 2026. ↩︎

  4. Scilife Help Center: Prefixes in the Design & Development tool. Vendor help center, updated 29 Jan 2026. ↩︎

  5. Scilife: Medical device product development software. Vendor product page and FAQ, checked 30 Sep 2026. ↩︎ ↩︎

  6. Scilife Help Center: How do I create an event?. Vendor help center, updated 24 Sep 2026. ↩︎

  7. Scilife: Quality events product tour. Vendor tour (step text checked), 30 Sep 2026. ↩︎

  8. Scilife Help Center. Vendor help center, 732 articles searched 30 Sep 2026. ↩︎

  9. Scilife Help Center: How do I create a project?. Vendor help center, updated 10 Sep 2026, checked 4 Oct 2026. ↩︎

  10. Scilife: Integrations. Vendor website, checked 30 Sep 2026. ↩︎

  11. Scilife: Pricing for medical devices. Vendor pricing page and FAQ, checked 30 Sep 2026. ↩︎ ↩︎ ↩︎ ↩︎ ↩︎

  12. Scilife pricing page, archived June 2021. Wayback Machine, checked 30 Sep 2026. ↩︎

  13. Scilife pricing page, archived March 2025. Wayback Machine, checked 30 Sep 2026. ↩︎

  14. Scilife Help Center: Will I be charged for a deactivated user?. Vendor help center, checked 30 Sep 2026. ↩︎

  15. Scilife: Terms and conditions. Vendor contract terms, version 2022-6, checked 1 Oct 2026. ↩︎ ↩︎ ↩︎

  16. Scilife: ISO 9001 certification. Vendor website, checked 30 Sep 2026. ↩︎

  17. Scilife: Privacy policy. Vendor legal page, checked 30 Sep 2026. ↩︎

  18. Greenlight Guru: Quality pricing and packages. Vendor website, checked 29 Sep 2026. ↩︎ ↩︎ ↩︎ ↩︎

  19. Greenlight Guru: Interactive product tour. Vendor product tour with screenshots (captured 2024), checked 30 Sep 2026. ↩︎

  20. Greenlight Guru: Product development software. Vendor website, checked 29 Sep 2026. ↩︎

  21. Greenlight Guru: Complaint management software. Vendor website, checked 29 Sep 2026. ↩︎

  22. Greenlight Guru: Legal and trust information. Vendor website, checked 29 Sep 2026. ↩︎

  23. Vendr: Greenlight Guru pricing. Price benchmark, checked 29 Sep 2026. ↩︎

  24. Qualio: Pharma quality management software. Vendor website, checked 29 Sep 2026. ↩︎

  25. Getting Started with Design Controls in Qualio. Vendor help center, checked 29 Sep 2026. ↩︎

  26. Qualio: Plans and pricing. Vendor website, checked 29 Sep 2026. ↩︎ ↩︎

  27. Qualio: Data Processing Addendum. Vendor legal page, checked 29 Sep 2026. ↩︎

  28. Terms and Policies (subprocessor list). Vendor help center, 24 Nov 2025. ↩︎

  29. Qualio product tour. Vendor website, checked 29 Sep 2026. ↩︎

  30. Forms and Qualio. Vendor help center, checked 29 Sep 2026. ↩︎

  31. Matrix One user manual: Traceability. Help center, checked 29 Sep 2026. ↩︎

  32. Matrix One user manual: GitHub and GitLab integration. Help center, checked 29 Sep 2026. ↩︎

  33. Matrix One blog: SxMD templates package. Vendor blog, published 2 Oct 2023. ↩︎

  34. Matrix One: Matrix Req product page, pricing section. Vendor price list (shown with JavaScript), checked in a browser 30 Sep 2026. ↩︎

  35. Matrix One: Free trial. Vendor website, checked 29 Sep 2026. ↩︎

  36. Matrix One: Matrix Quality product page, ROI calculator and FAQ. Vendor website, checked 29 Sep 2026. ↩︎

  37. Ketryx docs: How to generate the Design History File for your medical device (archived). Product documentation, captured 15 Oct 2025. ↩︎

  38. Ketryx: Certifications. Vendor website, checked 30 Sep 2026. ↩︎

  39. Ketryx: Sign up for a free trial. Vendor website, checked 30 Sep 2026. ↩︎

  40. Ketryx: Pricing. Vendor website, checked 4 Oct 2026. ↩︎

  41. Ketryx: AI-readable site index. Vendor website mirror (743 pages searched), checked 30 Sep 2026. ↩︎

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

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

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

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

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

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

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

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

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

  51. Scilife: eQMS validation. Vendor website, checked 30 Sep 2026. ↩︎

  52. Scilife Help Center: Validation documentation. Vendor help center, updated 27 Nov 2025. ↩︎

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

  54. G2: Scilife reviews, all pages. Review site, read in a browser while logged in, checked 2 Oct 2026. ↩︎

  55. Scilife Help Center: Traceability matrix. Vendor help center, updated 4 Mar 2026. ↩︎

Why people switch: Device-specific features are thin: risk isn't linked to design controls, complaints use a generic events workflow, and there's no Jira or Git integration. Read our Scilife review.

  1. 1

    OpenRegulatory Formwork

    OpenRegulatory (OpenReg GmbH), $7k/yr

    You're an early-stage device startup, especially one building software, and want a cheap, self-serve QMS with templates and linked requirements, risks and tests.Watch out: Complaints are logged as incidents with no documented investigation step, and we found no internal audit planning, UDI or DMR/DHR features. The vendor has no ISO 27001 certification and offers no audit rights.

    7.8out of 10
    Read the OpenRegulatory Formwork review OpenRegulatory Formwork alternatives
  2. 2

    Matrix Requirements (Matrix One)

    Matrix One (Matrix Requirements GmbH), from $22k/yr

    You build software or software-heavy devices and need design controls, risk and test traceability tied to your QMS.Watch out: A full QMS takes two products from Matrix One: Matrix Req, plus Matrix Quality, a Salesforce-based eQMS acquired in 2026 and priced separately.

    7.5out of 10
    Read the Matrix Requirements (Matrix One) review Matrix Requirements alternatives
  3. 3

    Greenlight Guru

    Greenlight Guru, from $12k/yr

    You build a medical device, want design controls, ISO 14971 risk and quality events linked in one MedTech-only system, and can budget well above the entry price.Watch out: Users report the bill growing quickly as the team grows, and implementation is charged on top of the subscription.

    7.4out of 10
    Read the Greenlight Guru review Greenlight Guru alternatives
  4. 4

    Cognidox

    Cognidox Ltd (part of Recur Software), from $8k/yr

    You run a small or mid-sized device company, want strong document control with Part 11 e-signatures at a low price, and are happy to shape your own CAPA, change and supplier forms.Watch out: Complaints, supplier, audit and design controls are thinly documented and largely document- or form-based. The validation pack and SSO are unpriced add-ons, and the LMS needs the Scale tier or an add-on.

    7.2out of 10
    Read the Cognidox review Cognidox alternatives
  5. 5

    SimplerQMS

    SimplerQMS A/S, from $17.5k/yr

    You run a small or mid-sized device or pharma company, write your SOPs in Microsoft Word, and want implementation, validation and training included in one yearly price.Watch out: Design controls, risk and software lifecycle are managed as documents with no native traceability, and contracts auto-renew with a 90-day notice period and a 5% yearly price rise.

    7.1out of 10
    Read the SimplerQMS review SimplerQMS alternatives
  6. 6

    Qualio

    Qualio, Inc., est. $12–30k/yr

    You're a growing device or combined device-and-pharma company that wants a QMS your whole team will actually use, with design controls linked to Jira and data hosted in the EU.Watch out: Prices aren't published, every plan carries an implementation fee, and complaint handling, vigilance reporting and production records aren't dedicated features.

    6.8out of 10
    Read the Qualio review Qualio alternatives
  7. 7

    Orcanos

    Orcanos Ltd., pricing on request

    You build a software-heavy or electromechanical device and want requirements, risk, tests and QMS records traced in one system rather than two tools joined by an integration.Watch out: Prices are not published, and supplier, audit, nonconformance and complaint workflows are described mainly on marketing pages rather than in the help center.

    6.7out of 10
    Read the Orcanos review Orcanos alternatives
  8. 8

    Arena QMS

    Arena, a PTC business, est. $12–25k/yr

    You build physical medical devices with outsourced manufacturing and want CAPA, complaints, training and design records linked to the same BOM and change orders as your engineering data.Watch out: Pricing is quote-only with paid implementation and validation add-ons. There is no risk register, IEC 62304 support or electronic regulatory reporting.

    6.6out of 10
    Read the Arena QMS review Arena QMS alternatives
  9. 9

    Ketryx

    Ketryx Corporation, pricing on request

    You build software as a medical device, your engineers live in Jira and Git, and you want design controls, risk and IEC 62304 records generated from that work.Watch out: We found no documented supplier, internal audit, DMR/DHR or vigilance-reporting workflows, so most device companies will run it next to another eQMS.

    6.5out of 10
    Read the Ketryx review Ketryx alternatives
  10. 10

    Ideagen Quality Management

    Ideagen, est. $22–29k/yr

    You make physical devices or combination products, want proven CAPA, audit, supplier and document workflows with Part 11 signatures, and handle design controls and risk files elsewhere.Watch out: Design controls, ISO 14971 risk files, vigilance reporting and IEC 62304 support aren't documented as product features, and the standard agreement defaults to 24 months with automatic renewal unless the order form says otherwise.

    6.4out of 10
    Read the Ideagen Quality Management review Ideagen Quality Management alternatives
  11. 11

    Dot Compliance

    Dot Compliance Ltd., pricing on request

    You run a device, pharma or combination-product company and want a pre-configured GxP quality system on Salesforce that goes live in weeks to a few months.Watch out: Prices, contract terms and data export aren't published, and there's no documented support for software development (IEC 62304) or developer tools.

    5.9out of 10
    Read the Dot Compliance review Dot Compliance alternatives
  12. 12

    ETQ Reliance (Octave Reliance)

    Octave Intelligence plc (formerly ETQ), pricing on request

    You run a multi-site medical device or combined device and pharma manufacturer and want one configurable system for documents, CAPA, complaints with eMDR, suppliers and audits across sites.Watch out: There's no design-controls, ISO 14971 risk-file or IEC 62304 module, and prices, contract length and hosting regions aren't published.

    5.1out of 10
    Read the ETQ Reliance (Octave Reliance) review ETQ Reliance alternatives
  13. 13

    MasterControl

    MasterControl Solutions, Inc., est. $25–72k/yr

    You run a larger, multi-site device or combined device-and-pharma quality organisation and need a configurable, validated system for documents, training, CAPA and audits.Watch out: Prices, hosting location and exit terms aren't published, and design controls, risk files and software development support are weak for device R&D teams.

    5.1out of 10
    Read the MasterControl review MasterControl alternatives
  14. 14

    Qualityze

    Qualityze Inc., pricing on request

    You make physical devices or combine devices and pharma, already use Salesforce or want to, and need configurable complaint, vigilance, CAPA and supplier workflows across several sites.Watch out: Design controls and FMEA are still unreleased roadmap items, there are no public prices, terms, DPA or hosting details, and many reviews were posted in year-end bursts.

    5.1out of 10
    Read the Qualityze review Qualityze alternatives

Scilife vs the top alternatives

ScilifeOpenRegulatory FormworkMatrix Requirements (Matrix One)Greenlight GuruCognidox
Built-in document editorNoLive Edit opens documents in desktop Microsoft WordYesRich-text editor with tables and images, stored as MarkdownYesRich-text editor for items and generated documentsNoDocuments are files; 2024 tour shows upload and download, editing via Office or GoogleNoDocuments are uploaded files edited in their own apps; forms are filled in the browser
Edit in Word or Google DocsYesMicrosoft Office integration with automatic versioningPartly or add-onGoogle Docs and Sheets edited in Google with sync; Word files can be uploaded but not edited in placePartly or add-onMatrix Quality only (Office 365, SharePoint/Google); Matrix Req imports Word but can't edit in itYesCo-edit in Google Docs and Microsoft Office for the webYesOffice add-in for Word, Excel and PowerPoint; cross-platform version needs Office 365
SOP templates includedNot confirmed yetNo SOP library found; only design-report templatesYesOpenRegulatory's free QMS and technical documentation templates built inYesSxMD SOP and document templates on Company plansYesQMS templates listed in the eQMS package; 70+ SOPs and formsPartly or add-onCAPA, NCR, change and other form templates included; SOP templates only mentioned vaguely
Jira or Git integrationNot confirmed yetNo Jira or Git integration listedNoVendor says there's no Jira or development-tool integration, by design; CI pipelines can file test results through the MCP APIYesJira, GitHub, GitLab and Azure DevOpsYesJira and GitHub integrationsPartly or add-onCommand-line client for source-control hooks and REST/SOAP API; no documented Jira or Git integration
IEC 62304 software featuresPartly or add-onFAQ claim only; no software-specific featuresYesSafety class per product, requirement categories, detailed design for class C, tests and test runsYesSoftware traceability and IEC 62304 templatesYesSoftware release management aligned to IEC 62304; SBOM scanningNot confirmed yetNo IEC 62304 features found
Validation package includedYesExecuted GAMP 5 package with IQ/OQ/PQ, includedYesPre-filled validation report with screenshots of each tested requirement, generated in the appYesValidation project with plans, tests and reportsYesIQ protocol plus OQ/PQ reports with every release, includedPartly or add-onValidation pack with IQ/OQ/PQ templates and test evidence, sold as an add-on
Public APIPartly or add-onREST API exists; documentation not publicPartly or add-onMCP (JSON-RPC) API with API tokens and a public tools reference; no REST APIYesDocumented REST API; Salesforce APIs for Matrix QualityPartly or add-onREST API exists; documentation is for customers onlyPartly or add-onREST and SOAP API; reference docs only inside the product; Scale tier or add-on
Single sign-on (SSO)YesMicrosoft Entra ID SSO with SCIM provisioningPartly or add-onGoogle sign-in; no SAML SSO foundYesMatrix Req: Enterprise Plus only; Matrix Quality via SalesforceYesSSO listed as a platform featurePartly or add-onSAML SSO (Entra ID, Google) on higher packages or as an add-on
Supplier portalNot confirmed yetSupplier questionnaires are uploaded manuallyNot confirmed yetSupplier list for your own evaluations; no supplier access foundYesMatrix Quality portal for supplier forms and SCARsPartly or add-onSecure sharing with suppliers; no dedicated portal documentedYesLimited Access Partner accounts give suppliers scoped access
Training with quizzesYesTraining assessments; AI beta drafts them from documentsYesTraining effectiveness by quiz or a named person (paid plans)YesMultiple-choice training questions in Matrix ReqYesAI drafts training quizzesYesLMS quizzes with question pools and pass marks (Scale tier or LMS add-on)
FDA MDR or EU vigilance reportingNot confirmed yetNo FDA MDR or EU vigilance reporting foundPartly or add-onIncidents record whether they are serious and reportable; no MDR or EU vigilance report formsPartly or add-onReportability assessment on a marketing page onlyPartly or add-onReportability decision and report task; no eMDR submissionNot confirmed yetNo FDA MDR or EU vigilance reporting feature found
AI featuresYesTwo AI beta features since Nov 2025YesAI drafting of QMS and technical documents; data goes to OpenAI only when you click generateYesMatrix Mind, AI design tools, compliance checkerYesGreenlight Guru AI: search, answers, summaries; ISO 42001Not confirmed yetNo AI features documented; the new owner plans to add AI

Frequently asked questions

What are the best Scilife alternatives?
It depends on why you’re leaving. Greenlight Guru links design controls, ISO 14971 risk and complaints for device-only companies. Qualio covers devices and drugs with design controls linked to risk. Matrix Requirements and Ketryx suit software teams that work in Jira and Git. SimplerQMS publishes a starting price that includes implementation and validation.
Is there a Scilife alternative with published prices?
Yes. SimplerQMS starts at $17,500 a year for up to 15 users (September 2026), including implementation, validation, data migration and training. Greenlight Guru publishes an entry price of $12,000 a year, with implementation quoted separately. Matrix Requirements publishes price lists for both of its products. Scilife has never published prices, including in archived pages back to 2021.
Which Scilife alternative links risk to design controls?
Greenlight Guru, Qualio, Matrix Requirements and Ketryx all document risk linked to design controls or requirements. In Scilife, risk assessments use FMEA only and risk items don’t exist in the Design and Development module.
Which Scilife alternative integrates with Jira and Git?
Ketryx syncs requirements, software items, tests and risks from Jira, Git and test tools and generates the design history file from them. Matrix Requirements links to Jira, GitHub, GitLab and Azure DevOps. We found no Jira or Git integration in Scilife.
When should I stay with Scilife?
Stay if you run GMP work alongside devices and value an included validation package. Scilife covers deviations, equipment qualification and controlled printing, ships an executed GAMP 5 package with IQ, OQ and PQ, and G2 reviewers rate its ease of use 8.6/10 (September 2026).