ReviewsKetryx

Ketryx review

A lifecycle-management platform that turns Jira, Git and test tools into audit-ready design records, with a lighter eQMS on top. Strongest for software devices; supplier, audit and production processes need another tool.

Price
on requestNo public or reported prices for paid plans
Free trial
Free trialSelf-serve 30 days, no credit card
EU hosting
EU availableAWS US or EU; plan terms not stated; public DPA
Last checked
Oct 2026
Placeholder data: some scores, prices and features on this page have not been verified yet.

What we like

  • Design history files, trace matrices and risk files are generated from Jira, Git and test tools, with documented workflows for each item type.
  • Self-serve 30-day trial of the full platform, eQMS included, with no credit card.
  • The platform itself is certified to ISO 13485, IEC 62304 and ISO 14971, and a validation package ships with every major and minor release.
  • Documented full-project export as a JSON archive, plus documents in Word, Excel and PDF.

What to watch

  • We found no documented supplier, internal audit, DMR/DHR, UDI or vigilance-reporting workflows.
  • No prices for paid plans, and no independent price reports either.
  • EU hosting exists, but no public source says whether it is available on every plan.
  • Only 2 reviews on G2 and no Capterra listing, so there's little independent user feedback.

About the price: No public prices for paid plans (Sep 2026). A $0 Free plan is limited to pre-market companies that raised under $2M. Self-serve 30-day trial.

What is Ketryx?

Ketryx Corporation was founded in 2021.1 It has offices in Cambridge, Massachusetts, and Vienna.2 It raised a $39M Series B in September 2025 and more than $55M in total.3 MedTech Dive reported three of the top five medtech companies as customers in 2025; Ketryx now says four of the top five.31

Ketryx isn’t a classic eQMS. It is a lifecycle-management layer on top of Jira, GitHub, GitLab, Azure DevOps, TestRail and Jama that syncs items and enforces approval rules.4 From that data it generates release documents such as the traceability matrix, risk management file, SRS and test reports.5 An eQMS layer adds document control, training, complaints and CAPA.6 Ketryx itself describes the platform as a bridge between engineering tools and your existing eQMS.7

Who Ketryx is for

The clearest fit is a software or AI device team whose developers already work in Jira and Git. Ketryx’s own platform is certified to IEC 62304, ISO 13485 and ISO 14971 by UL Solutions.8 Its customer stories are mostly SaMD and AI companies such as HeartFlow, Flo Health and Aignostics.91011

Hardware makers should be careful. Ketryx markets hardware requirements traceability.12 We found no documented workflow for supplier control, internal audits, production records (DMR/DHR), UDI or vigilance reporting.13 Its templated QMS includes SOPs for internal audit and purchasing, but those are documents, not system features.14 One customer, Oui Therapeutics, kept its eQMS and added Ketryx alongside it.15

Ketryx pricing

As of 30 September 2026, the pricing page lists four plans.16 Free costs $0 a year but is limited to pre-market companies that raised less than $2 million. Startup (for companies under 200 people), Business and Enterprise are “contact sales”.16

Archived versions of the page never showed a dollar price for a paid plan.1718 They do show the limits:

  • In 2024 the Free plan allowed up to 4 users.17
  • In 2024 onboarding support was listed only on the Growth and Enterprise plans.17
  • In November 2025 the Business plan allowed up to 70 users and included SOP templates and post-market surveillance.18

We found no price paid in reviews, forums or benchmark sites, so we can’t estimate a cost for a 10-person team. Professional services such as white-glove implementation exist; the page doesn’t say what they cost.19 The terms let Ketryx raise fees at renewal, with no cap.20

Features

Document control, records and training

The document system (EDMS) accepts uploaded files or documents written in a built-in editor. Documents enter a controlled state through approvals.21 Uploaded Word files can’t be edited in the browser; you upload a new revision instead.21 Document types can have their own approval rules, and the full text is searchable.2223 Google Drive folders can sync into the EDMS.24 SharePoint publishing is in a limited rollout.25

Training is assigned to groups per document, with a set frequency. Users read and acknowledge the document, and users who haven’t completed their training can’t approve on behalf of that group.2126 A training dashboard shows who still needs to train.27 We found no quizzes.

Design controls and risk

Requirements, software items, tests and risks sync from Jira, Git and test tools, and Ketryx generates the design history file from them.284 The risk module follows ISO 14971, with configurable probability and severity matrices and FMEA.29 Release gates can block a release until traceability is complete.30

Complaints, CAPA and change control

Work instructions document the full complaint lifecycle, including adverse-event types, investigation and a response to the complainant.31 The complaint workflow has no documented reportability or regulatory-report step.31 The CAPA workflow covers root cause analysis and effectiveness checks.32 Change requests record an impact assessment and quality approval.33 Nonconformance handling is claimed on the eQMS page. The documented workflow covers software anomalies only.634

Software development (IEC 62304)

This is Ketryx’s core. It tracks SOUP through a software bill of materials and emails users about new vulnerabilities in released versions.30 AI agents draft CAPAs and flag complaint trends, gated by human approval.6

What users say

On G2, Ketryx has 2 reviews averaging 4.8/5 as of September 2026, too few to use; there is no Capterra listing.35 Its Jira app on the Atlassian Marketplace has 12 reviews averaging 5.0, several from customers also quoted on Ketryx’s website.36 There, one small team reports setting up an IEC 62304 process and passing an audit within three months.36

On Reddit, first-hand reports are few and mixed:

  • One user reports a lot to learn and early performance problems, which a responsive team fixed.37
  • Another says the Jira integration was tricky to set up but became a “game changer”.38
  • A user moving from a traditional eQMS finds Ketryx short on flexibility and controls.39
  • A 2023 evaluator chose another tool for SBOM reports because Ketryx only checked top-level dependencies.40 Ketryx added transitive dependencies in March 2024.22

Security, hosting and validation

Ketryx holds ISO/IEC 27001:2022 (since May 2026) and has held SOC 2 Type 2 since 2023.8 The Trust Center’s subprocessor list names AWS as the host for all application and customer data, in the US and the EU.41 It doesn’t say whether EU hosting is the default for EU customers or available on every plan, so ask sales.41 Backups go to other AWS regions.42 The DPA is public and includes EU standard contractual clauses.43

A validation package comes with every major and minor release: a traceability matrix, use-case requirements, a testing report and release notes.44 It is shared through the Trust Center once you sign an NDA.41 Electronic signatures use approval groups and multi-factor authentication.45 Single sign-on works with Okta or any OpenID Connect provider.46

Buying and contract terms

  • Trial. You can start a 30-day all-access trial, eQMS included, without a credit card.47 There is also a recorded demo, and a live demo on request.4849
  • Contract term. The terms set a one-year initial term that renews automatically unless you give 60 days’ notice.20 The startup page instead promises monthly pricing and no minimum commitment, so confirm the term in your order.50
  • Export. A full project can be exported as a JSON archive.51 Documents export to Word, Excel and PDF, and the approval history exports to CSV.5253 APIs and webhooks are documented, though the docs now require a Ketryx login.54
  • Time to go live. Case studies report about 10 weeks to 3 months: HeartFlow saw results in 10 weeks, and Flo Health went from unregulated to audit-ready in under 90 days.910
  • Price increases. The terms let Ketryx raise fees at any time, effective from your next renewal, and set no cap.20 Because Ketryx has never published prices for paid plans, there is no list-price history to check, and we found no user reports of renewal increases. Ask for a renewal cap in your order form.
  • If Ketryx is sold or closes. The terms have no clause for returning your data or putting it in escrow if Ketryx becomes insolvent, stops the service or changes owner, and Ketryx may assign your contract without your approval.20 At the normal end of a contract, each side returns or destroys the other’s confidential information within 30 days, and the DPA returns or deletes personal data.2043 Use the JSON export before your contract ends.

Company and ownership

Ketryx Corp is a Delaware corporation, registered with the SEC under CIK 0001893458, with its address in Cambridge, Massachusetts.5556 Its Form D filings give 2021 as the year of incorporation.57 In November 2025 it registered an Austrian subsidiary, Ketryx GmbH in Vienna (Firmenbuch FN 665153t), with Ketryx Corporation as the shareholder.58

The company is privately held and venture-backed. It filed four Form D notices of equity sales with the SEC:55

  • 2021 and 2022: about $2M each.5759
  • November 2023: $14M, the Series A led by Lightspeed Venture Partners, with MIT’s E14 Fund and Ubiquity Ventures.6061
  • July 2025: $36.1M sold of $37.5M offered, part of the $39M Series B announced in September 2025. Transformation Capital led it, with Lightspeed, E14 Fund, Ubiquity Ventures and 53 Stations.563

Ketryx said in 2025 that it had raised more than $55M in total.3 Every Form D declines to disclose revenue, and we found no filed accounts.56 We found no acquisition of Ketryx and no reported layoffs.

Verdict

Shortlist Ketryx if you build software or AI devices and want design controls, risk and IEC 62304 records generated from Jira and Git. It is the strongest option here for that job. Don’t expect it to run a whole device QMS alone: plan for a separate tool for suppliers, audits and production records, and ask sales for prices and whether EU hosting comes with your plan.

  1. Ketryx: About the company. Vendor website, checked 30 Sep 2026. ↩︎ ↩︎

  2. Ketryx: Imprint. Vendor website, checked 30 Sep 2026. ↩︎

  3. MedTech Dive: AI firm Ketryx raises $39M, adds former Medtronic CEO as investor. Trade press, published 5 Sep 2025. ↩︎ ↩︎ ↩︎ ↩︎

  4. Ketryx docs: Integrations overview (archived). Product documentation, captured 8 Dec 2025, checked 30 Sep 2026. ↩︎ ↩︎

  5. Ketryx help center: Can I export Risk items from Ketryx? Help center, checked 30 Sep 2026. ↩︎

  6. Ketryx: eQMS. Vendor website, checked 30 Sep 2026. ↩︎ ↩︎ ↩︎

  7. Ketryx: Medical devices. Vendor website, checked 30 Sep 2026. ↩︎

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

  9. Ketryx: HeartFlow case study. Vendor case study, checked 30 Sep 2026. ↩︎ ↩︎

  10. Ketryx: Flo Health case study. Vendor case study, checked 30 Sep 2026. ↩︎ ↩︎

  11. Ketryx: Aignostics case study. Vendor case study, checked 30 Sep 2026. ↩︎

  12. Ketryx: Hardware-software medical device development. Vendor website, checked 30 Sep 2026. ↩︎

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

  14. Ketryx help center: How can I use Ketryx for ISO 13485 compliance? Help center, checked 30 Sep 2026. ↩︎

  15. Ketryx: Oui Therapeutics case study. Vendor case study, checked 30 Sep 2026. ↩︎

  16. Ketryx: Pricing. Vendor website, checked 30 Sep 2026. ↩︎ ↩︎

  17. Ketryx: Pricing (archived). Vendor website, captured 16 Sep 2024. ↩︎ ↩︎ ↩︎

  18. Ketryx: Pricing (archived). Vendor website, captured 19 Nov 2025. ↩︎ ↩︎

  19. Ketryx: Professional services. Vendor website, checked 30 Sep 2026. ↩︎

  20. Ketryx: Terms of Service. Vendor terms, checked 1 Oct 2026. ↩︎ ↩︎ ↩︎ ↩︎ ↩︎

  21. Ketryx docs: WI-11 Document (archived). Product documentation, captured 22 Apr 2024. ↩︎ ↩︎ ↩︎

  22. Ketryx: Ketryx 2.6 release. Release notes, published 29 Mar 2024. ↩︎ ↩︎

  23. Ketryx: Ketryx 2.9 release. Release notes, published 14 Oct 2024. ↩︎

  24. Ketryx docs: Google Workspace quality management documents (archived). Product documentation, captured 8 Dec 2025. ↩︎

  25. Ketryx: SharePoint integration. Vendor website, checked 30 Sep 2026. ↩︎

  26. Ketryx help center: Does Ketryx have a training matrix? Help center, checked 30 Sep 2026. ↩︎

  27. Ketryx: Ketryx 2.8 release. Release notes, published 21 Aug 2024. ↩︎

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

  29. Ketryx docs: MAN-08 Risk Management (archived). Product documentation, captured 22 Apr 2024. ↩︎

  30. Ketryx: Ketryx 2.11 release. Release notes, published 27 Jan 2025. ↩︎ ↩︎

  31. Ketryx docs: WI-07 Complaint (archived). Product documentation, captured 22 Apr 2024. ↩︎ ↩︎

  32. Ketryx docs: WI-09 CAPA (archived). Product documentation, captured 22 Apr 2024. ↩︎

  33. Ketryx docs: WI-08 Change Request (archived). Product documentation, captured 22 Apr 2024. ↩︎

  34. Ketryx docs: WI-06 Anomaly (archived). Product documentation, captured 22 Apr 2024. ↩︎

  35. G2: Ketryx Connected Lifecycle Management reviews. Review site, checked in a browser 30 Sep 2026. ↩︎

  36. Atlassian Marketplace: Ketryx Lifecycle Management for Jira. App marketplace reviews, checked 30 Sep 2026. ↩︎ ↩︎

  37. Reddit r/MedicalDevices: comment by a Ketryx user. Community post, Mar 2025. ↩︎

  38. Reddit r/ProductManagement: comment by a Ketryx user. Community post, Jul 2025. ↩︎

  39. Reddit r/MedicalDevices: Ketryx for eQMS. Community post, Sep 2026. ↩︎

  40. Reddit r/MedicalDevices: comment on SOUP automation. Community post, Jul 2023. ↩︎

  41. Ketryx Trust Center. Vendor trust center, checked in a browser 30 Sep 2026. ↩︎ ↩︎ ↩︎

  42. Ketryx help center: How often does Ketryx backup our data? Help center, checked 30 Sep 2026. ↩︎

  43. Ketryx: Data Processing Addendum. Vendor legal page, effective 24 Jun 2026. ↩︎ ↩︎

  44. Ketryx: Inside Ketryx’s customer validation package. Vendor blog, published 12 Dec 2025. ↩︎

  45. Ketryx docs: MAN-01 Ketryx Lifecycle Management (archived). Product documentation, captured 22 Apr 2024. ↩︎

  46. Ketryx help center: Which authentication methods does Ketryx support? Help center, checked 30 Sep 2026. ↩︎

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

  48. Ketryx: On-demand demo. Vendor website, checked 30 Sep 2026. ↩︎

  49. Ketryx: Request a demo. Vendor website, checked 30 Sep 2026. ↩︎

  50. Ketryx for start-ups. Vendor website, checked 30 Sep 2026. ↩︎

  51. Ketryx docs: MAN-13 Data Export (archived). Product documentation, captured 28 Apr 2025. ↩︎

  52. Ketryx help center: What options are available for documentation publication? Help center, checked 30 Sep 2026. ↩︎

  53. Ketryx help center: Can I access the record of a deleted document? Help center, checked 30 Sep 2026. ↩︎

  54. Ketryx docs: API (archived). Product documentation, captured 28 Apr 2025. ↩︎

  55. SEC EDGAR: Ketryx Corp filings (CIK 0001893458). US public filings, checked 1 Oct 2026. ↩︎ ↩︎

  56. SEC: Ketryx Corp Form D, filed 5 Sep 2025. US public filing, checked 1 Oct 2026. ↩︎ ↩︎ ↩︎

  57. SEC: Ketryx Corp Form D, filed 16 Nov 2021. US public filing, checked 1 Oct 2026. ↩︎ ↩︎

  58. North Data: Ketryx GmbH, Vienna (Firmenbuch 665153t). Austrian company register mirror, checked 1 Oct 2026. ↩︎

  59. SEC: Ketryx Corp Form D, filed 6 Jul 2022. US public filing, checked 1 Oct 2026. ↩︎

  60. SEC: Ketryx Corp Form D, filed 21 Dec 2023. US public filing, checked 1 Oct 2026. ↩︎

  61. Ketryx: Medtech AI developer Ketryx raises $14M in Series A round led by Lightspeed. Vendor reprint of a Medical Design and Outsourcing article, published 5 Dec 2023, checked 1 Oct 2026. ↩︎

Visit the Ketryx website (made by Ketryx Corporation)

Notable features

Built-in document editorYesBuilt-in text editor for EDMS documents
Edit in Word or Google DocsPartly or add-onGoogle Drive sync; SharePoint publishing in limited rollout; no in-browser Word editing
SOP templates includedPartly or add-on20 SOP templates; listed on higher plans in 2024–2025
Jira or Git integrationYesJira, GitHub, GitLab, Bitbucket, Azure DevOps
IEC 62304 software featuresYesIEC 62304-certified platform, SOUP/SBOM, anomalies, release gates
Validation package includedYesValidation package with every major and minor release
Public APIYesBuild, Project, Item and Group APIs, webhooks
Single sign-on (SSO)YesGoogle, GitHub, Okta or any OpenID Connect provider
Supplier portalNot confirmed yetNo evidence found
Training with quizzesNot confirmed yetRead-and-acknowledge training documented; no quizzes found
FDA MDR or EU vigilance reportingNot confirmed yetAdverse-event complaint types, but no documented MDR or vigilance reports
AI featuresYesAI agents for CAPA drafts, complaint trends and quality review

ISO 13485 clause coverage

ClauseRequirementKetryx
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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