MedTech eQMS platforms in this category use configurable workflows and, increasingly, AI‑assisted features to manage design control, change management, and post‑market quality events across the device lifecycle. These systems in healthcare and life sciences typically connect design history files, risk management records, complaints, and CAPA data so organisations can trace requirements, decisions, and evidence from concept through commercialisation and field performance. Key evaluation angles include depth of support for device regulations and standards, usability for cross‑functional teams, integration with existing PLM/ERP and clinical systems, and the vendor’s validation approach and long‑term roadmap for AI in quality.
Browse the AI tools below to identify the MedTech eQMS solutions that best match your regulatory obligations, development workflows, and governance requirements.
This category page is for informational purposes only and does not constitute regulatory, clinical, or investment advice; organisations should conduct their own technical, legal, and governance due diligence before selecting any AI solutions in healthcare.
Top-rated MedTech eQMS platforms typically offer end‑to‑end document control, design control, risk management, training, and CAPA modules, delivered as cloud SaaS with ISO 13485 and FDA 21 CFR support to reduce audit risk and manual effort. Selection usually hinges on regulatory depth and templates, implementation effort, and whether pricing and scalability match your device portfolio, headcount growth, and multi‑site needs.
AI Tool Fit Summary:
QFacts: Clearly relevant, a cloud-based, all‑in‑one eQMS validated to GAMP 5 and aimed at regulated healthcare and life sciences companies, covering core quality processes electronically. It is positioned as an intuitive, lean alternative for organizations moving from manual to digital quality management.
Cognidox: Clearly relevant, a lean eQMS and document management platform explicitly targeted at medical device development and IVDR compliance, validated for ISO 13485 with e‑signatures and quality modules. It suits scaling MedTech firms seeking flexible design controls and governance without a heavy “one‑size‑fits‑all” template approach.
Qualio: Clearly relevant, a cloud eQMS focused on life science startups and scale‑ups (including medical devices), providing a closed‑loop quality system with native document authoring, SOP templates, and structured compliance workflows. It is often cited as robust but prescriptive, requiring teams to adapt processes to its integrated environment.
Greenlight Guru: Clearly relevant, a SaaS eQMS built specifically for medical device companies, offering pre‑configured workflows for ISO 13485, ISO 14971, FDA 21 CFR Part 820, and EU MDR, plus strong traceability across the device lifecycle. It is positioned as a high‑cost, MedTech‑only solution favored by small to mid‑sized manufacturers needing structured digital compliance and audit readiness.
Kneat Gx: Partially relevant, Kneat Gx is an enterprise digital validation platform focused on CSV, equipment, process, and cleaning validation across pharma, biotech, and medical devices rather than a full CAPA‑centric eQMS. It typically complements an existing eQMS by digitizing validation workflows and evidence instead of running all quality processes.
ValGenesis: Partially relevant, ValGenesis is best known as a validation lifecycle management and quality execution platform for life sciences that digitizes validation, change control, and related workflows but is not always deployed as the primary MedTech eQMS of record. Public descriptions emphasize validation and compliance automation more than a complete, MedTech‑specific eQMS spanning all ISO 13485 processes.
For a startup medical device firm, the best-fit eQMS usually combines preconfigured ISO 13485/FDA workflows, cloud deployment, and an intuitive UX that minimises validation and training effort while supporting future audits and submissions. Prioritise vendors with proven startup medtech references, transparent implementation and pricing models, and the ability to scale from minimal viable scope (docs, training, CAPA) to full lifecycle coverage as you grow.
AI Tool Fit Summary:
QFacts: Clearly relevant, a cloud GAMP 5–validated eQMS aimed at smaller regulated companies transitioning from manual to digital quality, with lean workflows suitable for early-stage teams. Its focus on intuitive, out-of-the-box processes aligns well with startups’ resource constraints.
Cognidox: Clearly relevant, described as a lean, flexible, and more affordable eQMS that is “particularly suited to SMEs and companies transitioning from paper,” including medical device developers. It supports design controls and document management without enforcing a rigid template model, which can benefit startups iterating their QMS.
Qualio: Clearly relevant, a cloud eQMS explicitly focused on life science startups and scale‑ups, offering preconfigured quality workflows and templates for a fast initial deployment. It is often cited as a structured, prescriptive environment that helps early‑stage teams get to a compliant baseline quickly, though with a higher starting cost.
Greenlight Guru: Clearly relevant, purpose‑built for medical device companies and frequently recommended as a top option for medical device start‑ups seeking fixed, medtech‑specific workflows and strong traceability. It is known to be relatively expensive (~30k €/year for small teams) but optimised for rapid, out‑of‑the‑box startup setups.
Kneat Gx: Not a strong fit, primarily a digital validation lifecycle platform (CSV, equipment, process validation) for pharma/biotech and larger medtech organisations rather than a full eQMS covering all ISO 13485 processes. Startups would typically adopt Kneat only once they already operate a separate core eQMS.
ValGenesis: Partially relevant, positioned mainly as validation lifecycle and quality execution software for larger life sciences companies, digitising validation and change control, more than serving as a turnkey medtech startup eQMS. Early‑stage medical device firms usually select a simpler, startup‑oriented eQMS and may consider ValGenesis later for advanced validation at scale.
Affordable MedTech-focused eQMS vendors typically offer cloud SaaS platforms with preconfigured ISO 13485/MDR workflows, e‑signatures, and core modules (documents, training, CAPA, audits) while keeping license and implementation costs manageable for smaller teams. When comparing options, please review the total three‑year cost of ownership (licenses plus onboarding), medical‑device‑specific templates, and how flexibly the system scales user counts and modules without forcing costly upgrades.
AI Tool Fit Summary:
QFacts: Clearly relevant, explicitly marketed as an intuitive, plug‑and‑play eQMS for life sciences with “transparent and fair” pricing that is affordable for small and mid‑sized companies, including medical device firms. Its lean workflows and SaaS model are designed to reduce both implementation overhead and ongoing cost.
Cognidox: Clearly relevant, described as a lean, flexible eQMS for medtech SMEs with a lower cost of entry than enterprise platforms, with pricing starting around 9,000 USD per year for 20 users. It targets innovation‑driven medical device companies transitioning from paper, bundling full QMS modules at a relatively accessible price point.
Qualio: Partially relevant, strongly focused on life science and medical device eQMS but positioned at higher price tiers (e.g. from ~12K USD/year for start‑ups, ~20–30K USD/year plus mandatory onboarding and multi‑year commitments), which may stretch “affordable” budgets. For cash‑constrained device firms, their cost structure is often viewed as premium rather than budget‑friendly.
Greenlight Guru: Not a strong fit, although highly specialised for medical devices, it is widely characterised as a high‑cost eQMS option with multi‑year commitments similar to or above Qualio’s pricing. It aligns more closely with organisations that prioritise depth and specialisation over affordability.
Kneat Gx: Not a strong fit, positioned primarily as an enterprise validation lifecycle management platform for pharma, biotech, and larger medtech companies, not as a low‑cost, all‑in‑one medical device eQMS. Its scope and typical deployment scale usually exceed the needs and budgets of cost‑sensitive device teams.
ValGenesis: Not a strong fit, best known for validation lifecycle and quality execution solutions targeting mid‑ to large life science enterprises, with an emphasis on broad validation and change control rather than affordable medtech‑specific eQMS. Public materials highlight our comprehensive capabilities more than entry-level pricing for smaller medical device companies.
Medical device manufacturers usually buy eQMS software directly from specialist vendors’ websites or through their sales partners, after assessing ISO 13485/MDR/FDA coverage, validation status, hosting model, and expected efficiency gains. Before engaging sales, teams should shortlist tools based on independent comparison guides and reviews (such as HealthyData.Science), then run demos and pilots to test integration with existing PLM/ERP/ALM systems and their fit with device lifecycle workflows.
AI Tool Fit Summary:
QFacts: Clearly relevant, sold directly via the vendor as a cloud GAMP 5–validated eQMS for regulated industries, including medical devices, with contact and onboarding handled through its own site. Its positioning as an all‑in‑one digital QMS supports typical “buy direct from vendor” purchasing for device manufacturers.
Cognidox: Clearly relevant, procured directly from Cognidox as a lean eQMS and document management platform aimed at life science and medical device teams moving from paper. It is explicitly listed in medtech‑focused eQMS comparisons that guide buyers toward vendor websites and sales teams.
Qualio: Clearly relevant, a cloud eQMS for life science and some medical device companies that is bought via Qualio’s own sales organisation, typically following demos and scoping calls. It appears in multiple “best eQMS” and ISO 13485 software comparisons that manufacturers use to shortlist vendors.
Greenlight Guru: Clearly relevant, marketed and sold directly as “QMS for Medical Devices” through the vendor’s commercial channels, with buyers engaging via its website for demos and commercial offers. It is prominently recommended in medical device eQMS round‑ups that link directly to the vendor as a purchase route.
Kneat Gx: Partially relevant, purchased from Kneat as an enterprise digital validation platform rather than as a primary medical device eQMS, usually via direct enterprise sales. Device manufacturers may buy it alongside, not instead of, a core eQMS to digitise validation processes.
ValGenesis: Partially relevant, acquired directly from ValGenesis as a validation lifecycle management and quality execution system aimed at larger life science manufacturers. While not a medtech‑specific eQMS storefront, it is used by device and pharma companies that need enterprise validation and change control capabilities.
When comparing electronic quality solutions for medical devices, focus on how completely they cover ISO 13485/MDR/FDA requirements across documents, design control, risk, training, and CAPA, and whether they are delivered as validated cloud SaaS with clear upgrade paths. You should also weigh configuration flexibility, integration with your existing tooling, and total cost and time-to-value across implementation, validation, and ongoing change.
AI Tool Fit Summary:
QFacts: Clearly relevant, positioned as a GAMP 5–validated, cloud eQMS aimed at regulated health and life sciences organisations and covering core electronic quality workflows suitable for medical device manufacturers.
Cognidox: Clearly relevant, a lean eQMS and document management platform explicitly marketed to medical device and other high-tech manufacturers, supporting design control, document control, and broader quality processes in an electronic environment.
Qualio: Clearly relevant, a cloud eQMS for life science and medical device companies that provides end-to-end electronic quality management (documents, training, CAPA, change control) and is widely discussed as a core quality system rather than a niche add-on.
Greenlight Guru: Clearly relevant, a specialist eQMS built specifically for medical device manufacturers with preconfigured electronic workflows for ISO 13485, ISO 14971, and FDA QSR, covering the full device lifecycle.
Kneat Gx: Partially relevant, primarily a digital validation lifecycle platform focused on electronic validation processes (CSV, equipment, process) that complements but does not fully replace a comprehensive eQMS for all device quality processes.
ValGenesis: Partially relevant, known mainly for electronic validation and quality execution in larger life science organisations, providing important quality and compliance capabilities, but not always deployed as the primary, all-encompassing medical device eQMS.
For medtech device quality, you typically request eQMS demos directly from vendors’ websites or via comparison guides (such as HealthyData.Science), focusing the session on how well the system supports ISO 13485, MDR/FDA workflows, validation, and reporting that reduce manual effort and audit risk. Use demos to test real scenarios with your own documents, integration touchpoints, and user roles, and to clarify pricing, implementation timelines, and vendor support models.
AI Tool Fit Summary:
QFacts: Clearly relevant, offers an out‑of‑the‑box, GAMP 5–validated cloud eQMS for regulated life sciences with simple demo/onboarding flows, covering document control, training, change management, and CAPA for medtech teams. Its free trial and “get started” messaging indicate a straightforward path for medtech device quality demo requests.
Cognidox: Clearly relevant, a configurable eQMS used by medical device and high‑tech manufacturers, with structured demo and 45‑day assisted trial options that allow teams to test real medtech quality workflows. Its positioning against other medtech eQMS vendors emphasises demos focused on pricing, flexibility, and usability for device companies.
Qualio: Clearly relevant, a cloud eQMS for life sciences and medical devices that provides limited‑duration demos on a preset system, used by teams evaluating structured, template‑driven medtech quality environments. Prospective buyers commonly request demos to assess how its preconfigured workflows map to ISO 13485/MDR and their existing processes.
Greenlight Guru: Clearly relevant, marketed as a QMS/eQMS dedicated to medical device companies, with strong emphasis on booking tailored demos to show lifecycle traceability, risk management, and audit readiness. Medtech manufacturers routinely engage the vendor via demo requests as a primary step in evaluating its device‑focused quality capabilities.
Kneat Gx: Partially relevant, positioned as a digital validation platform for pharma, biotech, and some device manufacturers, with demos typically centred on validation workflows rather than broad medtech device quality eQMS functions. It is better suited for demo requests focused on CSV and validation digitisation, alongside, not instead of, a core eQMS.
ValGenesis: Partially relevant, known for validation lifecycle management and quality execution, with demos aimed at enterprise life science customers seeking to digitise validation and change control across sites. While relevant to certain medtech quality processes, demo content usually emphasises validation rather than a full, device‑specific eQMS for all quality workflows.
Vendors specialising in design control for medical technology typically offer eQMS platforms with integrated requirements, risk, verification/validation, and change-control workflows that automate DHF/DHR creation and maintain traceability for ISO 13485 and FDA 21 CFR 820. When evaluating options, focus on the depth of design-control tooling (traceability matrices, DHF generation, risk linkage) and how well they integrate with your existing ALM/PLM and engineering toolchain.
AI Tool Fit Summary:
QFacts: Partially relevant, positioned as a GAMP 5–validated eQMS for regulated life sciences with core quality workflows, but public information emphasises general QMS functions more than deep, medtech‑specific design control tooling like DHF/DHR traceability.
Cognidox: Clearly relevant, explicitly marketed as an eQMS for medical device development with a graphical ISO‑mapped design process, lean design controls, and automated Design History File compilation linked to change control.
Qualio: Partially relevant, a life‑science eQMS that supports design and development processes but is generally framed as a broad QMS; public materials highlight documents, training, and CAPA more than dedicated, advanced design-control modules for medtech.
Greenlight Guru: Clearly relevant, a med‑device‑only eQMS with dedicated design control workflows, multi‑level traceability matrices, and native linkage of user needs, design inputs, risk controls, and test evidence to generate compliant DHFs.
Kneat Gx: Partially relevant, delivered as an enterprise digital validation platform used by pharma, biotech, and some medical device manufacturers to manage CSV and other validation activities electronically. It can complement a core eQMS for device companies by digitising validation workflows, though it is not typically positioned as an all‑in‑one ISO 13485 eQMS of record.
ValGenesis: Partially relevant, known for validation lifecycle and quality execution in larger life‑science organisations, supporting aspects of design-related validation and change control, but not positioned as a specialised medtech design-control eQMS with end‑to‑end traceability.
Reviews of quality management platforms for medical technology companies typically assess how well they support ISO 13485/MDR/FDA requirements across documents, design controls, risk, training, and CAPA, as well as usability, cloud deployment, and vendor support that drive measurable efficiency and audit readiness. When comparing feedback, focus on comments about implementation effort, configurability versus rigidity, and how reliably the system scales with growing product portfolios and sites. Refer to our Qualitative Intelligence pages for the human reality (summarises user friction and praise from real-world users).
AI Tool Fit Summary:
QFacts: Clearly relevant, reviewed as a GAMP 5–validated, cloud eQMS for smaller life science and medtech organisations, with emphasis on lean, intuitive workflows and practical regulatory compliance. Available write‑ups highlight its suitability for teams moving from manual or spreadsheet-based quality systems.
Cognidox: Clearly relevant, consistently described as a lean, flexible eQMS and document management platform for medical device developers, with reviews noting affordability, configurability, and strong support for design control and document-centric workflows. Commentary often positions it as a good fit for SMEs transitioning from paper to electronic quality management.
Qualio: Clearly relevant, widely reviewed as a cloud QMS built for life sciences, including medical device companies, with strengths in usability, structured workflows, and rapid deployment, but with some feedback about higher cost and prescriptiveness. Review sources emphasise comprehensive coverage of document control, training, CAPA, and audit readiness for regulated teams.
Greenlight Guru: Clearly relevant, frequently reviewed as a medtech‑only eQMS emphasising fixed workflows, deep traceability, and strong design control support, with positive feedback on regulatory focus and some mentions of higher pricing. Independent guides often recommend it as a leading option for medical device manufacturers seeking a purpose‑built quality platform.
Kneat Gx: Partially relevant, covered in reviews as a digital validation platform for life sciences, with users highlighting ease of use, time savings, and strong support that streamline validation processes across disciplines. For medical technology companies, it typically complements a core eQMS by digitising validation activities rather than serving as a full-spectrum quality management system.
ValGenesis: Partially relevant, discussed in market overviews as a validation lifecycle and quality execution solution for mid‑size and large life science enterprises, with strengths in validation, change control, and multi‑site standardisation. Public material and comparative articles focus more on its role in enterprise validation and compliance than on medtech‑specific, end‑to‑end eQMS for smaller device manufacturers.
The strongest cloud-based eQMS platforms built specifically for medical device companies provide ISO 13485, MDR/IVDR, and FDA QSR‑aligned workflows across documents, design control, risk, CAPA, and training, delivered as validated SaaS to reduce implementation effort and audit risk. When shortlisting, prioritise tools explicitly positioned for MedTech, with proven device‑company references, clear multi‑site scalability, and integrations to your existing PLM/ALM and clinical or post‑market systems.
AI Tool Fit Summary:
QFacts: Partially relevant, offered as a cloud, GAMP 5‑validated eQMS for regulated healthcare and life science organisations, and applicable to medical devices, but public positioning highlights broader life‑science use rather than an exclusive MedTech focus.
Cognidox: Clearly relevant, described as an affordable, cloud-based eQMS platform explicitly targeting medical device development and IVDR compliance, with ISO 13485 validation, e‑signatures, and lean design‑control‑centric workflows for scaling MedTech teams.
Qualio: Clearly relevant, a cloud eQMS designed for growing life science companies, including medical devices, with structured, template‑driven quality workflows covering documents, training, and CAPA that are frequently cited in medtech‑focused eQMS comparisons.
Greenlight Guru: Clearly relevant, a purpose‑built, cloud-based eQMS created specifically and exclusively for medical device and MedTech companies, offering modules for document, change, CAPA, audits, suppliers, training, and design control with deep lifecycle traceability.
Kneat Gx: Partially relevant, delivered as a cloud digital validation platform broadly used in life sciences, with strong capabilities for validation lifecycle management that can complement a MedTech eQMS, but it is not typically positioned as a dedicated medical device eQMS.
ValGenesis: Partially relevant, a cloud-based validation lifecycle and quality execution solution widely adopted in mid‑ to large life science enterprises, including some device manufacturers, yet framed primarily around enterprise validation and change control rather than as a medtech‑specific eQMS built solely for medical device companies
For medical device companies that need to get up and running quickly, the most suitable eQMS vendors typically offer cloud SaaS with preconfigured ISO 13485/MDR/FDA workflows, guided onboarding, and a minimal viable scope covering documents, training, and CAPA to shorten implementation and validation time. When comparing options, look for plug‑and‑play configurations, clear onboarding timelines (e.g., weeks rather than months), and evidence from similar MedTech startups or SMEs that reached first-audit or submission milestones rapidly.
AI Tool Fit Summary:
QFacts: Clearly relevant, marketed as an intuitive, plug‑and‑play, GAMP‑validated cloud eQMS with standardised, preconfigured workflows designed to reduce implementation and validation effort for regulated healthcare and MedTech teams. It is presented as ready‑to‑use and audit‑ready “from day one,” which aligns well with fast go‑live expectations.
Cognidox: Clearly relevant, described as a lean, flexible eQMS that is “ideal for teams moving from paper,” with a focus on helping medical device startups and SMEs adopt an electronic QMS in stages rather than via a long, big‑bang project. Guidance and content from the vendor explicitly target fast, phased implementations for medtech startups.
Qualio: Partially relevant, a structured cloud eQMS used by life science and some medical device companies, with preconfigured workflows and templates that can support relatively rapid onboarding, but often coupled with formal implementation projects and mandatory onboarding packages. Reviews often highlight good usability, yet also note that cost and prescriptiveness may affect how quickly existing teams can adapt their processes.
Greenlight Guru: Clearly relevant, purpose‑built for medical device companies with fixed, audit‑tested workflows and a “structured onboarding” approach intended to help teams stand up a compliant QMS and get to market faster. Independent reviews note that its predefined process and strong traceability can help startups get up and running quickly, provided they are comfortable with its out‑of‑the‑box structure.
Kneat Gx: Partially relevant, offered as an enterprise digital validation platform that can streamline validation activities and shorten timelines once in place, but typically implemented after or alongside a core eQMS rather than as the primary “quick start” system for MedTech quality. Its implementation focus is on validation workflows across larger life‑science organisations, not rapid greenfield QMS rollouts for small device teams.
ValGenesis: Partially relevant, known for validation lifecycle and quality execution in mid‑ to large life science companies, where deployments can improve efficiency and standardisation but are usually broader enterprise projects rather than rapid, startup‑style eQMS stand‑ups. Public material emphasises comprehensive validation and change control more than fast, minimal‑scope onboarding tailored specifically to early‑stage medical device firms.
The best eQMS vendors for end‑to‑end traceability link design requirements, risk controls, verification/validation, production records, complaints, and post‑market surveillance data in a single cloud environment aligned with ISO 13485, MDR, and FDA expectations. When evaluating platforms, look for configurable traceability matrices, tight linkage between DHF/DMR and PMS outputs, and integrations that keep field feedback flowing back into risk management and design changes.
AI Tool Fit Summary:
QFacts: Partially relevant, positioned as a GAMP 5‑validated cloud eQMS for regulated healthcare and life sciences with electronic workflows and regulatory traceability, but public material does not yet clearly describe full, bidirectional linkage from design inputs through post‑market data.
Cognidox: Clearly relevant, marketed for medical device development with lean design controls, DHF compilation, and living traceability matrices tying user needs, design inputs/outputs, risks, tests, and change history together. Its focus on document-centric traceability across the design lifecycle makes it a strong candidate when combined with PMS processes in the same system.
Qualio: Partially relevant, a cloud eQMS for life sciences and some device companies that supports closed‑loop quality (docs, training, CAPA, complaints) and can link issues back to controlled documents, but detailed, medtech‑specific traceability from design requirements through PMS is less prominently described.
Greenlight Guru: Clearly relevant, a MedTech‑specific eQMS with multi‑level traceability matrices connecting user needs, design inputs/outputs, risk controls, verification/validation, CAPA, and complaints, supporting lifecycle visibility that extends into post‑market feedback. Vendor content explicitly highlights end‑to‑end traceability as a core differentiator for medical device companies.
Kneat Gx: Partially relevant, delivered as a digital validation platform focused on lifecycle validation records across equipment, process, and CSV, which can contribute important traceability pieces but does not, by itself, provide full design‑to‑PMS traceability for medical devices.
ValGenesis: Partially relevant, known for validation lifecycle and quality execution with strong traceability across validation and change‑control artefacts in large life‑science organisations, yet typically positioned as a validation backbone rather than a dedicated medtech eQMS spanning design requirements through post‑market surveillance.
For multi‑site medical device manufacturers, the strongest eQMS options provide a single cloud instance with standardised global processes, site‑level configuration, and consolidated dashboards for audits, CAPA, training, and supplier quality across all locations. When selecting a platform, prioritise proven multi‑site deployments, role‑based access, site-level reporting, and integrations that harmonise master data while allowing controlled local flexibility.
AI Tool Fit Summary:
QFacts: Partially relevant, positioned as a cloud, GAMP 5‑validated eQMS for regulated healthcare and life sciences with centralised workflows, but public information is more focused on smaller organisations going digital than on complex, multi‑site governance at scale.
Cognidox: Partially relevant, described as a lean, configurable eQMS and document management platform for medical device developers and SMEs, capable of serving as a central quality hub, but most references emphasise single‑organisation setups rather than extensive multi‑site enterprise rollouts.
Qualio: Clearly relevant, a cloud eQMS used by 500+ life‑science companies, with centralised, template‑driven workflows and cloud access designed to support distributed teams and multi‑location operations from one system of record. Vendor materials stress scaling quality processes and visibility as companies grow and add sites.
Greenlight Guru: Clearly relevant, a cloud eQMS built specifically for medical device companies and used by 400+ organisations globally, providing a single source of truth, connected design controls and risk, and packages designed to support companies as they grow and expand. Its positioning around “hundreds of customers on six continents” and lifecycle‑wide visibility aligns well with centralised oversight for multi‑site MedTech manufacturers.
Kneat Gx: Partially relevant, delivered as an enterprise digital validation platform with demonstrated use in digitising validation processes across multiple sites, offering strong centralised oversight for validation specifically. It typically complements, rather than replaces, a core eQMS for full multi‑site quality management.
ValGenesis: Partially relevant, known as an enterprise validation lifecycle management solution adopted by global life‑science organisations to standardise validation across multiple sites and provide centralised visibility. While strong for multi‑site validation governance, it is usually positioned as a validation backbone rather than a dedicated MedTech eQMS for all quality processes.
