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Best Medical Device QMS Software 2026

Best Medical Device QMS Software 2026. Compare documented quality workflows and commercial boundaries.

Verified 21 October 2026

20 products4 category-specific criteria

Ranked shortlist

6 of 20 publish a price · 2 offer a free plan · 2 offer a free trial

Rank1
Greenlight Guru eQMS
Why it ranks here: Greenlight Guru eQMS names ISO 13485, FDA QMSR, ISO 14971 and IEC 62304 for medical-device quality teams.
Not a fit if: you need a public rate for a regulated-device budget; Greenlight Guru eQMS starts at $12,000 per year.
Starting price
Greenlight Guru eQMS packages start at $12,000 per year; the page does not state a unit. · as of October 2026
Free plan
Not documented
Free trial
Not documented
Medical-device standards focus
ISO 13485, FDA QMSR, ISO 14971
21 CFR Part 11 support statement
Part 11 electronic signatures
Electronic signatures
Yes
Controlled document revision history
Yes
Review
Rank2
Ketryx eQMS
Why it ranks here: Ketryx names ISO 13485, ISO 14971, EU MDR, IVDR, 21 CFR Part 11 and Part 820 for regulated product teams.
Not a fit if: you run a device company beyond Ketryx’s stated pre-market and under-200-person segments.
Starting price
Not documented
Free plan
Yes
Free trial
Not documented
Medical-device standards focus
ISO 13485, MDR, 21 CFR Part 11
21 CFR Part 11 support statement
Part 11 design statement
Electronic signatures
Yes
Controlled document revision history
Yes
Review
Rank3
MedQdoc
Why it ranks here: MedQdoc lists ISO 13485:2016, ISO 14971:2019 and FDA 21 CFR Part 820 for device and IVD manufacturers.
Not a fit if: you must set an entry-price ceiling for device quality; MedQdoc starts at €410 per month.
Starting price
410€ / month — STARTUP, minimum 5 users · as of October 2026
Free plan
Not documented
Free trial
Not documented
Medical-device standards focus
ISO 13485:2016; ISO 14971:2019; FDA 21 CFR Part 820
21 CFR Part 11 support statement
Part 11 support; customer validation required
Electronic signatures
Yes
Controlled document revision history
Yes
Review
Rank4
Formwork
Why it ranks here: Medical-device startups can use Formwork’s free Community Edition, which includes ISO 13485, FDA Part 11, IEC 62304 and ISO 14971 templates.
Not a fit if: you need a device QMS for a company beyond the lean, founder-led startup segment; Formwork targets lean, founder-led medical-device companies.
Starting price
Community Edition: Free forever, with 5 user seats. · as of October 2026
Free plan
Yes
Free trial
Not documented
Medical-device standards focus
ISO 13485; FDA 21 CFR Part 11; IEC 62304; ISO 14971
21 CFR Part 11 support statement
FDA 21 CFR Part 11 compliant e-signatures
Electronic signatures
Not documented
Controlled document revision history
Not documented
Review
Rank5
Matrix Quality
Why it ranks here: Matrix Quality names ISO 13485, FDA Part 11 and GxP in its medical-device quality scope.
Not a fit if: you need a self-hosted QMS for regulated device records; Matrix Quality is offered as cloud SaaS.
Starting price
Not documented
Free plan
Not documented
Free trial
Not documented
Medical-device standards focus
ISO 13485; FDA 21 CFR Part 11; GxP
21 CFR Part 11 support statement
Not documented
Electronic signatures
Not documented
Controlled document revision history
Not documented
Review
Rank6
Orcanos eQMS
Why it ranks here: Orcanos names ISO 13485, EU MDR and 21 CFR Part 11 for medical-device quality teams.
Not a fit if: you need a public entry price to forecast device-system spend; Orcanos eQMS leaves its starting rate unlisted.
Starting price
Orcanos does not publish a numeric starting price on its pricing page. · as of October 2026
Free plan
Not documented
Free trial
Not documented
Medical-device standards focus
ISO 13485, EU MDR, Part 11
21 CFR Part 11 support statement
21 CFR Part 11 named
Electronic signatures
Yes
Controlled document revision history
Not documented
Review
Rank7
Propel QMS
Why it ranks here: Propel names ISO 13485:2016, EU MDR and FDA 21 CFR Part 820 in its medical-device quality scope.
Not a fit if: you cannot set a budget before vendor review without a posted rate; Propel QMS does not publish an entry price.
Starting price
Propel does not publish a numeric starting price on its pricing page. · as of October 2026
Free plan
Not documented
Free trial
Not documented
Medical-device standards focus
ISO 13485, EU MDR, Part 820
21 CFR Part 11 support statement
Part 11 support statement
Electronic signatures
Yes
Controlled document revision history
Yes
Review
Rank8
QIMS
Why it ranks here: QIMS names ISO 13485 and EU MDR 2017/745 for its medical-device quality offering.
Not a fit if: you need a public rate for a regulated-device budget; QIMS starts at €149 per month.
Starting price
Starter (maximum 3 users): ab 149 € / Monat. · as of October 2026
Free plan
Not documented
Free trial
Not documented
Medical-device standards focus
ISO 13485; EU-MDR 2017/745
21 CFR Part 11 support statement
Not documented
Electronic signatures
Not documented
Controlled document revision history
No
Review
Rank9
Qualio
Why it ranks here: Qualio describes risk-management support for ISO 14971 and ICH Q9 in life-sciences quality workflows.
Not a fit if: you need a stated cost to price an eQMS pilot; Qualio publishes pricing by request, not a starting rate.
Starting price
Not published. Qualio provides a tailored quote after a conversation. · as of October 2026
Free plan
Not documented
Free trial
Not documented
Medical-device standards focus
ISO 14971 risk management
21 CFR Part 11 support statement
Part 11-compliant e-signatures
Electronic signatures
Yes
Controlled document revision history
Yes
Review
Rank10
1factory Quality Management System
Why it ranks here: 1factory names ISO 13485 among standards supported by its manufacturing QMS.
Not a fit if: you have fewer than ten device-quality users; 1factory bills a 10-user minimum at $20 per QMS user per month.
Starting price
Quality Management System: $20 per QMS user / month, 10 user minimum; minimum one-year subscription billed annually. · as of October 2026
Free plan
Not documented
Free trial
Not documented
Medical-device standards focus
ISO 13485
21 CFR Part 11 support statement
Part 11 compliant sign-in
Electronic signatures
Yes
Controlled document revision history
Yes
Review
Rank11
Veeva QualityOne
Why it ranks here: Veeva QualityOne captures signature execution in audit trails stated to comply with Annex 11 and 21 CFR Part 11.
Not a fit if: you cannot place device records in vendor-hosted infrastructure; Veeva QualityOne is cloud SaaS.
Starting price
Not documented
Free plan
Not documented
Free trial
Not documented
Medical-device standards focus
Not documented
21 CFR Part 11 support statement
Part 11 compliant audit trails
Electronic signatures
Yes
Controlled document revision history
Yes
Review
Rank12
Octave Reliance
Why it ranks here: Octave states that electronic signatures support 21 CFR Part 11 and EU Annex 11, with audit trails and validation support.
Not a fit if: you require self-hosted software for regulated records self-hosted software; Octave Reliance uses cloud SaaS.
Starting price
Not published
Free plan
Not documented
Free trial
Not documented
Medical-device standards focus
Not documented
21 CFR Part 11 support statement
Part 11 signatures; Life Sciences record validation support
Electronic signatures
Yes
Controlled document revision history
Yes
Review
Rank13
MasterControl Quality Excellence
Why it ranks here: MasterControl provides Part 11-compliant electronic signatures for controlled procedures.
Not a fit if: you need list pricing before you forecast device-system spend; MasterControl Quality Excellence has no public starting amount.
Starting price
Not published. MasterControl provides pricing tailored to the organization. · as of October 2026
Free plan
Not documented
Free trial
Not documented
Medical-device standards focus
Not documented
21 CFR Part 11 support statement
Part 11-compliant signatures
Electronic signatures
Yes
Controlled document revision history
Yes
Review
Rank14
QT9 QMS
Why it ranks here: QT9 states that its QMS is FDA 21 CFR Part 11 compliant.
Not a fit if: you need a stated cost to set a budget before vendor review; QT9 QMS publishes pricing by request, not a starting rate.
Starting price
QT9 provides custom pricing based on users and deployment requirements; no starting price is stated. · as of October 2026
Free plan
Not documented
Free trial
QT9 offers a free trial.
Medical-device standards focus
Not documented
21 CFR Part 11 support statement
FDA 21 CFR Part 11 compliant
Electronic signatures
Yes
Controlled document revision history
Yes
Review
Rank15
isoTracker Quality Management Software
Why it ranks here: isoTracker names ISO 13485 among its supported quality-management standards.
Not a fit if: you must host your eQMS in-house; isoTracker Quality Management Software is cloud SaaS.
Starting price
Not documented
Free plan
Not documented
Free trial
isoTracker offers a 60-day free trial of its full version.
Medical-device standards focus
ISO 13485 medical-device focus
21 CFR Part 11 support statement
FDA 21 CFR Part 11 support
Electronic signatures
Yes
Controlled document revision history
Yes
Review
Rank16
Qualios
Why it ranks here: Qualios Monitoring is designed to comply with FDA 21 CFR Part 11.
Not a fit if: you need an upfront price for a regulated-device QMS; Qualios lists no public starting price.
Starting price
Not published · as of October 2026
Free plan
Not documented
Free trial
Not documented
Medical-device standards focus
Not documented
21 CFR Part 11 support statement
Designed for 21 CFR Part 11
Electronic signatures
Yes
Controlled document revision history
Yes
Review
Rank17
uniPoint QMS
Why it ranks here: uniPoint identifies ISO 13485 among the medical-device standards supported by its QMS.
Not a fit if: you cannot set a device-quality procurement ceiling without a posted rate; uniPoint QMS does not publish an entry price.
Starting price
uniPoint directs buyers to request a specific quote; no starting price is stated. · as of October 2026
Free plan
Not documented
Free trial
Not documented
Medical-device standards focus
ISO 13485 Medical quality standard
21 CFR Part 11 support statement
Not documented
Electronic signatures
Not documented
Controlled document revision history
Yes
Review
Rank18
SoftExpert QMS
Why it ranks here: SoftExpert QMS lists ISO 13485 among its supported quality standards.
Not a fit if: you need list pricing to approve a design-control pilot; SoftExpert QMS starts at R$1,690 per month for three licences.
Starting price
The “Quero ser cliente SoftExpert” SGQ plan is R$ 1.690,00 monthly; the package includes three nominal licenses and renews annually. The page does not state a per-user price. · as of October 2026
Free plan
Not documented
Free trial
Not documented
Medical-device standards focus
ISO 13485 listed
21 CFR Part 11 support statement
FDA 21 CFR Part 11 listed
Electronic signatures
Not documented
Controlled document revision history
Yes
Review
Rank19
Inspection Manager / 360 CORE
Why it ranks here: Inspection Manager / 360 CORE lists ISO 13485 among the standards in its quality scope.
Not a fit if: you need a public amount to approve regulated-device software spend; Inspection Manager / 360 CORE lists no starting price.
Starting price
Not published · as of October 2026
Free plan
Not documented
Free trial
Not documented
Medical-device standards focus
ISO 13485 named for PPAP packages
21 CFR Part 11 support statement
Not documented
Electronic signatures
Yes
Controlled document revision history
Yes
Review
Rank20
Arena QMS
Why it ranks here: Arena QMS names FDA, ISO and EU MDR requirements for regulated product development.
Not a fit if: you need a device QMS centered on manufacturing execution rather than regulated product development; Arena QMS serves regulated product development.
Starting price
Not documented
Free plan
Not documented
Free trial
Not documented
Medical-device standards focus
FDA, ISO and EU MDR
21 CFR Part 11 support statement
Not documented
Electronic signatures
Not documented
Controlled document revision history
Not documented
Review

Start with Greenlight Guru eQMS for medical-device quality teams: its documented evidence leads this shortlist under the rule below. The cards identify each product’s buyer fit and a concrete workflow or commercial distinction; the matrix keeps unknowns visible instead of treating them as absent.

Vendors that explicitly position their quality product for medical devices or life sciences and name device regulations/standards rank above general QMS tools that merely list ISO 13485 or Part 11. Within those groups, more documented medical-device standards rank first, then documented CAPA and audit workflows, then published price transparency. No numeric score is assigned.

Review the linked vendor pages for plan boundaries and operating scope before choosing a deployment. Browse the QMS hub or return to the Help Desk category.

How we assessed this shortlist

Compare the deciding features

Category-specific workflows and plan requirements

Best Medical Device QMS Software 2026: documented features
Product	Medical-device standards focus	21 CFR Part 11 support statement	Electronic signatures	Controlled document revision history
Greenlight Guru eQMS	Greenlight Guru lists ISO 13485, FDA QMSR, ISO 14971 and IEC 62304.[1]	Greenlight Guru states that document control captures Part 11 electronic signatures.[1]	Greenlight Guru states that document control captures Part 11 electronic signatures.[2]	Greenlight Guru describes document control for keeping the current version in use.[2]
Ketryx eQMS	Ketryx names ISO 13485, ISO 14971, EU MDR, IVDR, 21 CFR Part 11 and 21 CFR Part 820.[3]	Ketryx states that its approvals and signatures are designed to meet 21 CFR Part 11 requirements.[3]	Ketryx describes browser biometric authentication for approvals and signatures.[3]	Ketryx says its document control includes automated version control and a full audit trail.[3]
MedQdoc	ISO 13485:2016; ISO 14971:2019; FDA 21 CFR Part 820[4]	Designed to support Part 11; customer assessment and validation remain required[4]	MedQdoc describes electronic signature workflows.[4]	MedQdoc lists document version control.[4]
Formwork	ISO 13485; FDA 21 CFR Part 11; IEC 62304; ISO 14971[5]	FDA 21 CFR Part 11 compliant e-signatures[5]	Not documented[6]	Not documented[6]
Matrix Quality	ISO 13485; FDA 21 CFR Part 11; GxP[7]	Not documented[8] [7]	Not documented[7]	Not documented[7]
Orcanos eQMS	Orcanos names ISO 13485, EU MDR and 21 CFR Part 11.[9] [10]	Orcanos names 21 CFR Part 11 in its CAPA lifecycle compliance statement.[10]	Orcanos describes e-signature in its electronic audit management offering.[11]	Not documented[9]
Propel QMS	Propel names ISO 13485:2016, EU MDR and FDA 21 CFR Part 820.[12]	Propel describes its offering as supporting FDA 21 CFR Part 11 requirements.[12]	Propel describes electronic records and signatures for its MedTech compliance offering.[12]	Propel QMS manages document revisions and retains change history.[12]
QIMS	ISO 13485; EU-MDR 2017/745[13]	Not documented[13]	Not documented[13]	Document control with version history is planned and is not part of the product scope today.[13]
Qualio	Qualio says risk management supports compliance with ISO 14971 and ICH Q9.[14]	Qualio states that Part 11-compliant e-signatures support document review, training completion and event close-out.[15]	Qualio describes its document lifecycle management as including compliant e-signatures.[16]	Qualio lists document control with version control.[17]
1factory Quality Management System	1factory names ISO 13485 among the standards for which its manufacturing QMS supports compliance.[18]	Validated sign-in is identified as 21 CFR Part 11 compliant.[19]	1factory lists eSignature as a 21 CFR Part 11 option.[20]	1factory documents authoring, redlines, and document versioning.[20]
Veeva QualityOne	Not documented[21]	Annex 11 and 21 CFR Part 11 compliant audit trails capture signature execution.[22]	Veeva QMS audit trails capture signature execution.[22]	Veeva QualityDocs provides document control workflows.[23]
Octave Reliance	Not documented[24]	Octave states support for electronic signatures under 21 CFR Part 11 and EU Annex 11, and says Life Sciences records include audit trails, signatures and validation support.[25] [25]	Octave says Reliance supports electronic signatures for 21 CFR Part 11 and EU Annex 11.[25]	Octave Reliance includes document control.[24]
MasterControl Quality Excellence	Not documented[26]	21 CFR Part 11-compliant electronic signatures for controlled documents[27]	MasterControl supports electronic signatures for controlled documents.[27]	MasterControl tracks document revision history.[27]
QT9 QMS	Not documented[28]	QT9 states that its QMS is FDA 21 CFR Part 11 compliant.[29]	QT9 says QT9 QMS supports electronic signatures and audit trails.[28]	QT9 says its QMS document control provides version control and full revision tracking.[28]
isoTracker Quality Management Software	ISO 13485 medical device QMS focus[30]	The platform supports FDA 21 CFR Part 11 compliance for electronic records and signatures.[31]	isoTracker supports electronic signatures for records.[31]	isoTracker document management includes version control and controlled document procedures.[32]
Qualios	Not documented[33]	Qualios Monitoring is designed to comply with FDA 21 CFR Part 11.[34]	Qualios offers an Electronic Signature module.[34]	Qualios Doc documents versioning, user-action tracking and history in its validation workflow.[35]
uniPoint QMS	uniPoint identifies ISO 13485 (Medical) as a supported quality standard.[36]	Not documented[37]	Not documented[37]	uniPoint controls document revisions and history.[36]
SoftExpert QMS	SoftExpert lists ISO 13485 in its QMS standards and regulations section.[38]	SoftExpert lists FDA 21 CFR Part 11 in its QMS standards and regulations section.[38]	Not documented[39]	SoftExpert QMS describes version control and a complete document lifecycle.[39]
Inspection Manager / 360 CORE	High QA identifies ISO 13485 requirements for PPAP submission packages.[40]	Not documented[40]	High QA documents digital signatures with digital traceability and multi-role workflows.[40]	HQA 360 documents revision control and version history for drawings and inspection plans.[40]
Arena QMS	PTC names FDA, ISO and EU MDR for Arena QMS.[41]	Not documented[41]	Not documented[41]	Not documented[41]

Evidence and sources

Greenlight Guru Quality (QMS Software) Pricing & PackagesRetrieved 2026-10-21T19:31:04Z
Aligned to ISO 13485, FDA QMSR, ISO 14971, and IEC 62304.
Greenlight Guru Quality (QMS Software) Pricing & PackagesRetrieved 2026-10-21T19:00:58Z
Document control Keep the current version in use, route approvals, and capture Part 11 electronic signatures without managing the process through email.
Medical Device Electronic Quality Management System (eQMS) - KetryxRetrieved 2026-10-21T21:03:44Z
Supporting compliance with 21 CFR Part 11, ISO 13485, ISO 14971, EU MDR, IVDR, and 21 CFR Part 820.
MedQdoc FAQ | eQMS, ISO 13485, MDR & Data SecurityRetrieved 2026-10-21T20:53:15Z
The system also supports quality management requirements aligned with ISO 13485:2016, ISO 14971:2019, and FDA 21 CFR Part 820.
OpenRegulatory Formwork PricingRetrieved 2026-10-21T20:53:15Z
ISO 13485 Compliance Set up a fully ISO 13485 - compliant QMS. FDA 21 CFR Part 11 Compliance Sign documents with FDA 21 CFR Part 11 compliant e-signatures. IEC 62304 Requirements Management (unlimited) Manage software requirements and tests compliant with IEC 62304. ISO 14971 Risk Management (unlimited) Perform an ISO 14971-compliant risk analysis for your medical device.
OpenRegulatory Formwork eQMS Software For Medical DevicesRetrieved 2026-10-21T20:53:15Z
The affordable eQMS for medical device teams. The most affordable eQMS software for lean, founder-led companies. EU MDR, FDA and Health Canada audits passed.
eQMS Software for life science companies | Matrix QualityRetrieved 2026-10-21T20:53:15Z
Pre-configured workflows and templates aligned with FDA 21 CFR Part 11, ISO 13485, and GxP standards.
Get Bespoke Pricing for Your Team | Matrix OneRetrieved 2026-10-21T20:53:15Z
Pricing tailored to your team Tell us which products you need and your team size. We build a proposal around your exact requirements, not a generic tier. Matrix One pricing is bespoke. We do not sell generic tiers.
Orcanos - eQMS & ALM Software for Medical Devices | ISO 13485Retrieved 2026-10-21T21:03:44Z
ISO 13485 and EU MDR compliance without the legacy overhead. Go live in 14 days with best-practice templates and adaptive workflows.
CAPA Management System: Analyze & Prevent Risk | OrcanosRetrieved 2026-10-21T21:03:44Z
Orcanos enables full automation of the CAPA lifecycle - from initiation to investigation and closure - ensuring compliance with industry regulations such as ISO 13485 and 21 CFR Part 11.
Audit Management Software SystemRetrieved 2026-10-21T21:03:44Z
The Orcanos Electronic Audit Management offers a secure and centralized web-based platform with smart dashboards, automation of workflows, and e-signature along with tractability to other quality processes, such as Nonconformance, FMEA, Training, Verification, Complaints, and CAPA.
AI QMS Software – Propel SoftwareRetrieved 2026-10-21T21:03:44Z
Traceability and easy-to-manage workflows keep product development on track while maintaining compliance with ISO 9001:2015 and ISO 13485:2016 requirements.
QIMS für Medizintechnik — ISO 13485 & EU-MDR BranchenlösungRetrieved 2026-10-21T20:53:15Z
ISO 13485 + EU-MDR — Prüfungen geplant, Messdaten nachvollziehbar. QIMS bringt Prüfplanung, Messdatenerfassung und Auswertung für Medizinproduktehersteller in ein System — mit unveränderlichem Audit-Log (append-only). CAPA, Risikomanagement und Dokumentenlenkung sind in Entwicklung.
QMS software: quality management tool for life science companiesRetrieved 2026-10-21T20:58:43Z
Detect and mitigate risks and comply with ISO 14971 and ICH Q9.
Regulatory Compliance Management Software— QualioRetrieved 2026-10-21T19:27:09Z
All major system actions, from document review to training completion and event close-out, underpinned by Part 11-compliant e-signatures
Quality Document Management Software — QualioRetrieved 2026-10-21T19:00:58Z
Create, review, approve, and distribute controlled documents from one place. Version history is automatic. Every change is recorded in an immutable audit trail. Part of the Qualio compliance platform.
Pricing - get a quote for your new eQMS todayRetrieved 2026-10-21T19:00:58Z
After an initial conversation to understand your business and requirements, we will provide a tailored quote.
QMS Software for Manufacturing | Simplify Compliance. Ace your Audits.Retrieved 2026-10-21T19:00:58Z
Go live in days, ace audits effortlessly, and maintain complete regulatory compliance for ISO 9001, AS9100, ISO 13485, 21CFR Part 11 and more.
QMS Software for Manufacturing | Simplify Compliance. Ace your Audits.Retrieved 2026-10-21T19:27:09Z
Validated Sign In 21 CFR Part 11 Compliant
Plans & PricingRetrieved 2026-10-21T19:00:58Z
21 CFR Part 11 eSignature Software Validation (initial and on-going)
Quality Management Software for Regulated Industries Veeva QualityOneRetrieved 2026-10-21T19:12:41Z
Veeva QualityOne accelerates the delivery of high-quality products. Our cloud platform unifies QMS, HACCP, document control, and training workflows.
Veeva QualityOne QMS Features BriefRetrieved 2026-10-21T19:27:09Z
Annex 11 and 21 CFR Part 11 compliant audit trails capture every event in a process, including execution of a signature, task creation and assignment, and more.
Veeva QualityDocs Features BriefRetrieved 2026-10-21T19:27:09Z
Predefined lifecycles, document types, and workflows enable efficient document control processes. This helps users stay on task with approval, authoring, training, release, review and withdrawal processes.
Octave Reliance | OctaveRetrieved 2026-10-21T19:28:54Z
Octave Reliance. Formerly ETQ Reliance. Flexible, configurable quality management system built to scale.
Octave Reliance | OctaveRetrieved 2026-10-21T19:08:39Z
Built on enterprise-grade AWS cloud infrastructure, it offers encryption in transit and at rest, role-based access control, SSO/LDAP and disaster recovery protocols. It complies with ISO 27001 and supports electronic signatures for 21 CFR Part 11 and EU Annex 11.
Experts in Quality Management - MasterControl QMS SoftwareRetrieved 2026-10-21T19:00:58Z
MasterControl’s digital quality management software (QMS), Quality Excellence, automates quality throughout the entire product life cycle to help companies navigate ever-changing regulations and standards, streamline processes, demonstrate compliance and make quality a true competitive differentiator.
Document Control Software - Experts in Quality ManagementRetrieved 2026-10-21T19:27:09Z
Maintains all documents in a centralised location that is easily searchable and provides a time-stamped audit trail, reporting and electronic signatures that are 21 CFR Part 11 compliant.
Document Control Software | QT9 QMSRetrieved 2026-10-21T19:08:39Z
QT9’s document control software simplifies how companies manage quality documents. From SOPs and work instructions to policies and procedures, QT9 helps automate version control, approvals and employee acknowledgment tracking. Fully integrated within QT9 QMS, it helps maintain compliance with ISO, FDA and EU regulations and simplifies audit readiness.
QT9 Software Pricing | QMS & ERP PlansRetrieved 2026-10-21T19:31:04Z
Custom pricing based on your users and deployment requirements. QT9 pricing scales with the number of concurrent users and whether you deploy via cloud or on-premise. Cloud Subscription or On-Premise deployment. FDA 21 CFR Part 11 Compliant.
What is ISO 13485? - isoTrackerRetrieved 2026-10-21T19:31:04Z
What is ISO 13485? The Quality Management Standard for Medical Devices
What is ISO 13485? - isoTrackerRetrieved 2026-10-21T19:27:09Z
The platform also supports FDA 21 CFR Part 11 compliance for electronic records and signatures – a critical requirement for regulated manufacturers.
isoTracker Cloud-Based Quality Management SoftwareRetrieved 2026-10-21T19:08:39Z
Review and approve documents, maintain version control, record change requests, follow correct change procedures, set automated review reminders
QMS Software: Quality Management with QualiosRetrieved 2026-10-21T19:17:33Z
The QMS package for Qualios software allows you to quickly and easily set up your quality management system, meeting the regulatory requirements of the ISO 9001 V2015 standard.
Additional modules | QualiosRetrieved 2026-10-21T19:34:06Z
These are in fact 3 modules that allow a higher traceability and a reinforced security of your data. This module is designed to comply with the requirements of the 21CFR Part 11 of the FDA. It is composed of the modules : Qualios Premium Analysis, Qualios Audit Trail and Qualios Electronic Signature.
DMS Software with Qualios (Document Management)Retrieved 2026-10-21T19:17:33Z
The validation workflow includes document versioning, user action tracking and history, providing maximum traceability.
Quality Management Software Key Functions | uniPoint Software Inc.Retrieved 2026-10-21T19:18:00Z
uniPoint quality management software, you have all the tools to comply with ISO standards, and can even meet the strict standards for ISO 13485 (Medical), AS9100 (Aerospace), and any other ISO-based quality standard your business requires.
Quality Management Software Key Functions | uniPoint Software Inc.Retrieved 2026-10-21T19:17:33Z
With uniPoint quality management software, you can monitor fully-integrated data from your ERP in real-time, track supplier management, non-conformance, trend analysis, auditing, and feedback surveys.
SoftExpert QMS | Quality Management SoftwareRetrieved 2026-10-21T20:58:43Z
ISO 13485
SoftExpert QMS | Quality Management SoftwareRetrieved 2026-10-21T19:08:39Z
Complete quality management system for continuous improvement, compliance, and performance. Automate and integrate audits, nonconformities, documents, and risks with Artificial Intelligence. Apply the PDCA Cycle, comply with ISO 9001, and monitor KPIs through dashboards.
Inspection Manager / 360 Core | High QARetrieved 2026-10-21T19:17:33Z
Build and manage full submission packages aligned with IATF 16949 and ISO 13485 requirements.
Arena PLM and QMS Solutions | PTCRetrieved 2026-10-21T21:03:44Z
You must be able to comply with standards such as ISO, FDA, IAQG, EU MDR, and more to drive commercialization success.

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