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Healthcare MedicineTop 10 Best Medical Device Regulatory Compliance Software of 2026
Top 10 medical device regulatory compliance software tools ranked by document control, audit trails, and regulatory workflow needs for teams.
How we ranked these tools
Core product claims cross-referenced against official documentation, changelogs, and independent technical reviews.
Analyzed video reviews and hundreds of written evaluations to capture real-world user experiences with each tool.
AI persona simulations modeled how different user types would experience each tool across common use cases and workflows.
Final rankings reviewed and approved by our editorial team with authority to override AI-generated scores based on domain expertise.
Score: Features 40% · Ease 30% · Value 30%
Gitnux may earn a commission through links on this page — this does not influence rankings. Editorial policy
Dot Compliance (on Salesforce) is the best pick if you need controlled document workflows and change control with traceable audit history, while ComplianceQuest fits med-device teams that want configurable regulatory workflows and API-driven integration for ongoing obligations.
Editor’s top 3 picks
Three quick recommendations before you dive into the full comparison below — each one leads on a different dimension.
Dot Compliance
Linked change control actions tie decisions to the specific documents and records under review, reducing version drift during audits.
Built for fits when teams need controlled document workflows and change control with traceable audit history..
RIMSYS
Editor pickDocument workflow traceability that links revisions, review decisions, and downstream tasks inside regulatory evidence packs.
Built for fits when regulated teams need document and change governance for submission evidence and follow-on updates..
Greenlight Guru
Editor pickEvidence status tracking tied to controlled documents and approvals across submission package assembly and post-market actions.
Built for fits when regulated teams need one controlled workflow for evidence, changes, and corrective actions..
Related reading
Comparison Table
Dot Compliance
vertical specialistCloud quality management software built on the Salesforce platform for regulated industries.
Linked change control actions tie decisions to the specific documents and records under review, reducing version drift during audits.
Dot Compliance is tailored for regulated documentation workflows with controlled documents, approval routing, and traceable edit histories that map to audit expectations. Change control processes are handled inside the same governed workspace as the underlying quality records, which reduces the need to reconcile versions across tools during internal reviews. Admin governance is centered on permissioned access and enforced document lifecycle states, which helps keep reviewers from editing artifacts outside defined steps.
A key tradeoff is that deeper integration into an existing QMS ecosystem depends on the team’s workflow fit and the way work is modeled inside Dot Compliance. It is a strong fit when regulatory documentation and quality records need consistent versioning and evidence linking across design updates, CAPA inputs, and audit follow-up activities.
- +Document lifecycle controls with enforced states and traceable edits
- +Change control workflows keep decisions linked to the affected records
- +RBAC-style governance supports controlled reviewer and approver roles
- +Audit trail records actions across document and workflow steps
- –Workflow configuration needs disciplined process mapping to avoid rework
- –Not all regulated artifacts are represented by one unified schema view
- –Some cross-team coordination still requires external collaboration tools
- –Advanced reporting depends on how processes are structured in the system
Regulatory affairs teams
Manage updates tied to submissions artifacts
Fewer reconciliation gaps during review cycles
Quality management teams
Run change control across evidence sets
Clear decision history for audits
Show 2 more scenarios
Compliance operations teams
Coordinate document reviews for audits
Faster audit package assembly
Permissioned access and action history help maintain controlled handling of regulated documentation.
Device program teams
Track governed updates across stakeholders
Reduced version confusion across teams
Structured lifecycle states reduce edits outside defined steps and keep review records consistent.
Best for: Fits when teams need controlled document workflows and change control with traceable audit history.
More related reading
RIMSYS
vertical specialistRegulatory information management software for medical device and life sciences companies.
Document workflow traceability that links revisions, review decisions, and downstream tasks inside regulatory evidence packs.
RIMSYS organizes regulatory and quality artifacts into governed workflows with approval steps, traceable edits, and controlled revisions. Teams can coordinate work across writers and reviewers while keeping audit-ready history of who changed what and when. Change control workflows help prevent orphan updates by linking revised documents to dependent tasks.
A tradeoff is that RIMSYS works best when teams adopt its document workflow model early rather than trying to retrofit existing processes. It fits organizations preparing EU MDR technical documentation cycles where evidence gathering, review, and revision tracking must stay consistent across multiple workstreams.
- +Revision history ties regulatory evidence updates to review outcomes
- +Workflow states support controlled authoring and gated approvals
- +Change handling reduces duplicate evidence across document sets
- +Audit trail coverage supports traceability for internal reviews
- –Best results require process alignment to RIMSYS workflow structure
- –Limited visibility into cross-system data flows without integrations
- –Complex governance rules can slow changes without clear roles
- –Automation depth depends on how tightly processes map to artifacts
Regulatory operations teams
Manage EU MDR evidence updates
Fewer mismatched evidence versions
Quality managers
Run controlled document change workflow
Improved traceability for audits
Show 2 more scenarios
RA and post-market teams
Coordinate post-market surveillance evidence
More consistent post-market reporting
Post-market teams organize and review evidence artifacts with revision control to keep reports consistent.
Clinical documentation teams
Maintain CER-aligned documentation sets
Reduced rework in approvals
Clinical contributors keep controlled revisions aligned with dependent documents during review cycles.
Best for: Fits when regulated teams need document and change governance for submission evidence and follow-on updates.
Greenlight Guru
vertical specialistQuality management software designed for medical device development and regulatory compliance.
Evidence status tracking tied to controlled documents and approvals across submission package assembly and post-market actions.
Greenlight Guru centers on controlled documentation, change workflows, and corrective actions tied to the quality system lifecycle. Teams can manage design and technical documentation evidence, maintain review and approval histories, and connect nonconformities to investigations and corrective actions. Audit log coverage supports audit trail expectations for electronic records and electronic signatures across the workflow.
A tradeoff is that deeper integration with existing engineering tooling requires deliberate integration planning rather than relying on a default data pipeline. Greenlight Guru works best when regulatory, quality, and product teams need one workflow home for evidence status, review routing, and post-market action tracking across multiple products.
- +Workflow-first design keeps approvals, revisions, and evidence linked
- +CAPA and complaint processes support end-to-end corrective action routing
- +Strong audit trail coverage for controlled electronic records workflows
- +Submission-ready organization by product and package reduces rework
- –Requires configuration discipline to keep workflows and roles consistent
- –External tool integration takes setup work for engineering-centric teams
- –Advanced reporting needs careful mapping of fields to processes
Regulatory operations teams
Assemble and maintain submission packages
Faster update cycles for submissions
Quality managers and CAPA owners
Run CAPA through investigation to closure
More consistent corrective action outcomes
Show 2 more scenarios
Product quality assurance leads
Coordinate complaint handling actions
Clearer linkage from complaint to action
Route complaints through triage, investigation, and corrective actions with traceable record changes.
Cross-functional compliance admins
Govern roles and audit trail requirements
Higher audit confidence
Enforce controlled document workflows and maintain audit histories across regulated activities.
Best for: Fits when regulated teams need one controlled workflow for evidence, changes, and corrective actions.
ComplianceQuest
enterpriseCloud quality, safety, and compliance management software for regulated organizations.
Workflow configuration that turns quality and regulatory cases into structured, auditable work items with API-accessible state changes.
ComplianceQuest brings regulatory compliance workflow automation into medical device quality operations with configurable lifecycle processes for documents, investigations, and CAPA.
The system centers on an extensible workflow engine that routes work items, captures decisions, and maintains traceable records for regulated activities.
It also provides integration and automation hooks via an API so teams can connect issue intake, status changes, and reporting to other QMS systems.
Reporting and audit support are driven by the same workflow data so evidence can be assembled without re-keying across disconnected tools.
- +Configurable workflow routing for investigations through CAPA closure
- +API access for synchronizing work status with external systems
- +Built-in audit trail across approvals, changes, and task history
- +Reporting based on workflow activity reduces duplicate evidence work
- –Complex rule sets can slow onboarding for new process owners
- –Document control depth can feel uneven versus enterprise document suites
- –Some integrations depend on middleware for data mapping
- –Admin governance needs disciplined role setup to avoid sprawl
Best for: Fits when med-device teams need configurable regulatory workflows with API-driven integration and audit-trace reporting.
AssurX
enterpriseQuality and compliance management software for regulated industries.
Controlled regulatory workflows that enforce approval states and preserve audit trails for every change across submission artifacts.
AssurX manages medical device regulatory compliance workflows across submission and post-market lifecycles, with configuration focused on common regulatory artifacts and review gates. The system ties document generation, controlled updates, and approval sequences to audit-ready evidence so teams can trace what changed and why.
It supports governance through role-based access controls, audit trails, and enforced review states across regulatory work products. AssurX also targets automation through templates and repeatable procedures for recurring submissions and continuing obligations.
- +Workflow templates map recurring regulatory tasks to consistent approval gates
- +Audit trails support evidence collection for document and decision history
- +RBAC and review-state controls reduce unauthorized edits in regulated areas
- +Automation reduces manual rework when generating and updating compliance packages
- –Document model alignment to DHF and DMR practices can require initial configuration discipline
- –Advanced integrations depend on available API and connector coverage
- –Complex multi-organization processes may require careful role and state design
- –Some regulatory edge cases may need custom workflow adjustments
Best for: Fits when regulatory teams need controlled workflows, audit evidence, and repeatable generation for ongoing obligations.
MasterControl
enterpriseEnterprise quality and document management software for regulated product organizations.
End-to-end linkage between nonconformance findings, CAPA actions, and review histories with audit trail retention for investigations.
MasterControl is built for regulated quality operations that require controlled documentation, traceable approvals, and consistent review routing across departments.
Document control and electronic signature workflows provide controlled record updates with audit trail visibility tied to specific approval events.
Change control workflows connect upstream review decisions to updates in controlled artifacts and maintain review history for audit review cycles.
Investigation-oriented workflows connect nonconformance outcomes to CAPA action planning and closure tracking with audit-ready history.
- +Configurable workflow steps for approvals across controlled documents and records
- +Strong audit trail coverage for edits, approvals, and signature events
- +Change control ties review decisions to downstream updates and histories
- +CAPA and nonconformance workflows keep investigations and actions linked
- –Workflow and role setup requires governance discipline to avoid approval sprawl
- –Some cross-system reporting requires custom configuration work
- –Admin tooling for complex hierarchies can feel heavy during iterative changes
- –Advanced integrations often depend on technical resources
Best for: Fits when regulated teams need audit-traceable workflows for controlled documents, changes, and investigations across sites.
Veeva Vault Quality
enterpriseCloud quality management software for life sciences and regulated manufacturing.
Quality workflow audit trail tied to governed configuration so investigators and reviewers can trace decisions across quality events.
Veeva Vault Quality is a Veeva Vault quality suite built for regulated medical device organizations that must connect controlled quality workflows to audit-ready records. It supports document and change workflows, nonconformance and CAPA tracking, and quality investigations with audit trail capture for compliance evidence.
Its integration depth with the wider Veeva Vault ecosystem helps teams link quality events to other regulated data sets and workflows. Admin controls focus on governed configurations, role-based access, and traceable activity logging across quality processes.
- +Configurable quality workflows with consistent audit trail capture
- +Tight fit for regulated record types and quality event lifecycles
- +Governed access controls designed for cross-functional quality teams
- +Strong ecosystem integration for connected regulated processes
- –Quality configuration work requires disciplined governance ownership
- –Some workflows depend on how integrations and references are modeled
- –User experience can feel heavy for teams doing minimal quality processing
- –Extensibility can increase admin overhead when templates diverge
Best for: Fits when regulated medical device teams need controlled quality workflows with audit evidence and governed access across multiple functions.
Arena QMS
enterpriseProduct lifecycle and quality management software for regulated product development.
Workflow-based nonconformance handling ties investigation, actions, and evidence into a single traceable path.
Arena QMS is a medical device regulatory compliance workflow system built for teams that need controlled documentation, reviews, and change paths. It supports eQMS-style activities like document control, electronic approvals, and audit-ready histories across regulated quality processes.
Arena QMS also covers core nonconformance handling workflows so teams can manage investigations through corrective actions and evidence. Integration depth depends on the available configuration and any provided API or export mechanisms, which can limit how tightly it plugs into existing lab, ERP, or PLM systems.
- +Document workflows support controlled creation, revision, and review trails
- +Nonconformance process pages consolidate investigation and corrective action steps
- +Configurable approval flows fit multi-role medical device review patterns
- +Audit trail visibility supports traceability during internal reviews
- –Regulatory submission workflows can require setup to match internal templates
- –Integration options are less explicit than process-specific workflow depth
- –Advanced risk and clinical evidence links need careful process mapping
- –User management features can be limiting for complex tenant governance
Best for: Fits when mid-size medical device teams need controlled eQMS workflows without custom engineering.
Qualio
SMBCloud quality management software for life sciences companies.
Cross-linking between change decisions, impacted records, and evidence packs helps keep regulatory trails coherent across audits.
Qualio manages regulated document and process workflows for medical device quality teams, with a focus on controlled content and traceable execution. Document control, change control, and audit management workflows are built around review, approval, and evidence collection for regulatory use cases.
The system supports quality investigations and corrective actions with status tracking and linkage across related records. Qualio also covers core post-market and complaint related processes used to maintain ongoing compliance across quality and regulatory teams.
- +Controlled document workflows that maintain versioning, approvals, and audit trails
- +Change control workflows link decisions to affected documents and downstream records
- +Investigation and corrective action tracking with status and evidence routing
- +Audit management supports planning, findings capture, and closure workflows
- –Advanced automation requires careful configuration of templates and workflow steps
- –Integrations depend on API-driven connections rather than out-of-the-box tool chaining
- –Role separation and governance need deliberate setup to prevent workflow sprawl
- –Reporting depth can feel constrained for organizations with highly customized metrics
Best for: Fits when medical device teams need controlled workflows and traceability across documents, changes, and investigations.
Ennov Quality
enterpriseQuality management software for life sciences and regulated product organizations.
Cross-linking of quality events to controlled documents for audit-traceable corrective action histories.
Ennov Quality is a medical device regulatory compliance software approach that centers on quality and regulatory workflows tied to controlled documentation. It supports document control, change workflows, and traceability across quality records used for audits and readiness activities.
It also provides CAPA and nonconformance handling workflows that connect events to corrective actions and verification. Automation features focus on workflow routing, status transitions, and governance around approvals and audit-ready recordkeeping.
- +Workflow-driven quality processes with clear status transitions and approvals
- +Document control operations that support regulated record management needs
- +CAPA and nonconformance handling tied to corrective action tracking
- +Audit trail emphasis across quality events and related records
- –Limited evidence of deep regulatory modules for MDR technical documentation generation
- –Automation coverage appears strongest in document and quality workflows
- –Integration and API surface details are not clearly positioned for external systems
- –Requires disciplined configuration to keep routing and approvals consistent
Best for: Fits when teams need end-to-end quality workflows that support regulatory readiness and audit evidence.
Conclusion
After evaluating 10 healthcare medicine, Dot Compliance stands out as our overall top pick — it scored highest across our combined criteria of features, ease of use, and value, which is why it sits at #1 in the rankings above.
Use the comparison table and detailed reviews above to validate the fit against your own requirements before committing to a tool.
How to Choose the Right medical device regulatory compliance software
This buyer's guide covers medical device regulatory compliance software choices across Dot Compliance, RIMSYS, Greenlight Guru, ComplianceQuest, AssurX, MasterControl, Veeva Vault Quality, Arena QMS, Qualio, and Ennov Quality.
It focuses on controlled documentation workflows, traceable change and review decisions, evidence pack organization, CAPA and investigation routing, and the API and automation hooks needed for integration with adjacent QMS systems.
Medical device regulatory compliance software for governed evidence, workflows, and audit-traceable records
Medical device regulatory compliance software manages controlled regulatory documentation and quality workflows with audit trail retention across approvals, changes, and investigation outcomes. It solves traceability breakpoints that occur when evidence is edited in one place and referenced in another during internal reviews and submission package assembly.
Tools like Dot Compliance and RIMSYS model regulatory work as document and workflow lifecycles so revisions, gated approvals, and downstream tasks stay linked for auditors and internal stakeholders.
Regulatory control mechanisms to evaluate for medical device compliance workflows
Evaluating this category requires comparing how each platform connects controlled documents to review states and downstream work items. That linkage determines whether evidence remains coherent when teams assemble technical documentation, post-market activities, and corrective actions.
The next set of criteria also separates teams that need API-driven state changes from teams that can operate inside a single governed workflow environment, which changes the required extensibility and admin governance approach.
Linked change control decisions to affected regulatory records
Dot Compliance ties change control actions to the specific documents and records under review, which reduces version drift during audits. Qualio also links change decisions to impacted records and evidence packs to keep regulatory trails coherent across audits.
Evidence pack traceability from revisions to review outcomes and downstream tasks
RIMSYS links regulatory evidence updates to review outcomes and downstream tasks inside evidence packs. Greenlight Guru extends the same concept into submission package assembly and post-market actions with evidence status tracking tied to controlled documents and approvals.
Configurable workflow engine with audit-traceable work items and API-accessible state changes
ComplianceQuest uses an extensible workflow engine that routes regulatory cases through investigations and CAPA closure with audit trails driven by the same workflow data. It also provides API access so external systems can synchronize work status changes instead of rebuilding status manually in another tool.
Approval-state governance across controlled regulatory workflows
AssurX enforces approval states across controlled regulatory workproducts and preserves audit trails for every change across submission artifacts. MasterControl provides configurable workflow steps for approvals plus electronic signature events, which supports audit-ready evidence for regulated document edits and approvals.
End-to-end linkage for nonconformance to CAPA actions with investigation histories
MasterControl connects nonconformance findings to CAPA actions and review histories with audit trail retention for investigations. Arena QMS concentrates this same linkage into nonconformance process pages that consolidate investigation, corrective actions, and evidence into one traceable path.
Governed quality workflow audit trail tied to configuration and access controls
Veeva Vault Quality captures audit trail tied to governed configuration so investigators and reviewers can trace decisions across quality events. It pairs that audit evidence with governed access controls designed for cross-functional quality teams.
Decision framework for selecting regulatory compliance workflow software
Start with the workflow center of gravity, because each tool in this set optimizes traceability in different ways. Dot Compliance and RIMSYS emphasize document lifecycle and evidence pack governance, while ComplianceQuest and Greenlight Guru shift traceability into workflow execution and evidence assembly paths.
Next evaluate integration depth and admin governance, because audit trace that spans multiple systems depends on how API and automation surfaces map states and evidence references across tools.
Pick the traceability anchor: documents or workflow work items
Choose Dot Compliance when controlled document lifecycles and governed edit history are the primary traceability anchor for regulatory audits. Choose RIMSYS when revision history must tie regulatory evidence updates to review outcomes and downstream evidence pack tasks.
Match your corrective-action workflow model to the tool’s path
Choose MasterControl when nonconformance outcomes must link directly to CAPA actions and investigation review histories with strong audit trail retention. Choose Arena QMS when nonconformance handling should be consolidated into a single traceable path that covers investigation, actions, and evidence.
Confirm whether state changes must be API-synchronized across systems
Choose ComplianceQuest when external systems need API-accessible state changes that stay aligned with workflow routing for investigations and CAPA closure. Choose Veeva Vault Quality when audit-trace needs to remain inside the Veeva Vault ecosystem with governed access controls and configuration-backed audit evidence.
Validate how evidence assembly and submission packaging should be organized
Choose Greenlight Guru when evidence status tracking must tie controlled documents and approvals to submission package assembly and post-market actions. Choose Qualio when cross-linking between change decisions, impacted records, and evidence packs must keep regulatory trails coherent during internal audit planning.
Stress-test governance setup effort against process alignment requirements
Choose AssurX when repeatable regulatory task templates and consistent approval gates are required for ongoing obligations, even if initial document model alignment needs configuration discipline. Choose RIMSYS or Dot Compliance when disciplined process mapping is acceptable, because workflow configuration determines whether traceability stays clean without rework.
Which teams benefit from regulatory compliance workflow software
Teams should choose based on how they run regulated work and where evidence coherence breaks during reviews. Some tools focus on controlled document lifecycles and change governance, while others focus on workflow-driven cases that drive audit evidence.
Selecting the right tool also depends on whether governance must span multiple functions and whether state changes must synchronize to external systems.
Regulatory teams that need controlled document lifecycles with audit-traceable change history
Dot Compliance fits teams that need enforced document lifecycle states, traceable edits, and RBAC-style governance for reviewers and approvers. Qualio fits when controlled document workflows must also connect change decisions to impacted records and evidence packs.
Regulated teams that assemble submission evidence packs and must preserve revision-to-decision traceability
RIMSYS fits teams that need revision history tying evidence updates to review outcomes and downstream tasks inside regulatory evidence packs. Greenlight Guru fits teams that need evidence status tracking tied to controlled documents and approvals across submission package assembly and post-market actions.
Quality and regulatory operations teams that run investigation and CAPA routing as auditable work items
ComplianceQuest fits teams that require configurable workflow routing for investigations through CAPA closure with API access for state synchronization. MasterControl fits teams that need end-to-end linkage between nonconformance findings, CAPA actions, and review histories with audit trail retention.
Enterprise regulated organizations that already rely on Veeva Vault ecosystem governance
Veeva Vault Quality fits regulated medical device teams that need audit-trail capture tied to governed configuration and access controls across quality event lifecycles. Veeva Vault Quality is also a strong fit when cross-functional quality teams require governed access and consistent traceability across quality processes.
Mid-size teams that want controlled eQMS-style workflows without heavy custom engineering
Arena QMS fits mid-size medical device teams that want document control, electronic approvals, and audit-ready histories plus consolidated nonconformance handling. Ennov Quality fits teams that want end-to-end quality workflows with cross-linking of quality events to controlled documents for audit-traceable corrective action histories.
Common buying pitfalls for medical device regulatory compliance workflow platforms
Most failures in this category come from mismatched workflow design to the team’s actual regulatory artifacts and approval gates. Other failures come from underestimating governance setup effort or assuming reporting will work without careful field and process mapping.
These pitfalls show up across the reviewed tools and directly affect audit traceability, change coherence, and integration accuracy.
Mapping workflows without disciplined process alignment
Dot Compliance and RIMSYS can require disciplined workflow configuration to avoid rework when approval states and evidence references do not match real operating procedures. RIMSYS also slows progress if governance rules are complex and roles are not clearly defined for each workflow step.
Assuming reporting works automatically without aligning fields to process structure
Dot Compliance notes that advanced reporting depends on how processes are structured in the system. Greenlight Guru and ComplianceQuest also require careful mapping of fields to processes so audit evidence can be assembled without duplicate effort or mismatched outputs.
Ignoring API and automation requirements for cross-system state changes
ComplianceQuest is built for API-driven integration with workflow state changes, so teams that need external synchronization should verify API coverage early. RIMSYS and AssurX can show limited visibility into cross-system data flows when integrations are not in place, which increases manual coordination.
Expecting one platform schema to represent every regulated artifact in the same way
Dot Compliance states that not all regulated artifacts are represented by one unified schema view, which can force workarounds for specific artifact types. Ennov Quality also shows limited evidence of deep regulatory modules for MDR technical documentation generation, so teams needing that generation should validate workflow coverage.
Under-designing role separation and governance controls
MasterControl and Veeva Vault Quality can require governance discipline to avoid approval sprawl and configuration overhead. Qualio also requires deliberate role separation and governance setup to prevent workflow sprawl when teams customize processes and metrics.
How We Selected and Ranked These Tools
We evaluated Dot Compliance, RIMSYS, Greenlight Guru, ComplianceQuest, AssurX, MasterControl, Veeva Vault Quality, Arena QMS, Qualio, and Ennov Quality on features, ease of use, and value, then calculated an overall score as a weighted average where features carried the most weight and ease of use and value each counted as a large share.
This criteria-based scoring came from editorial research that uses the provided feature and capability descriptions for each tool, not from hands-on lab testing or private benchmark experiments.
Dot Compliance set itself apart with tightly linked change control actions that tie decisions to the specific documents and records under review, which directly lifted its features factor through traceable audit history. That same trace linkage also supports a smoother day-to-day workflow flow for controlled documents, which raised ease-of-use and value in regulated document workflows.
Frequently Asked Questions About medical device regulatory compliance software
How does change control trace decisions to specific controlled records across these tools?
Which tools provide an extensible workflow engine with API-driven workflow state changes?
How do teams migrate existing document control data models and approval history into a new platform?
When should a team treat submission evidence packs as a core data object instead of separate document folders?
What breaks if external QMS or enterprise systems cannot call a regulatory platform API for status updates?
How do admin controls and RBAC enforcement differ across platforms?
Which platforms support audit trail capture across document lifecycle actions like routing, approval, and governed edits?
How does each tool connect CAPA or nonconformance work to the regulatory documentation trail?
Where do integration depth constraints show up for lab, ERP, or PLM connections?
Tools reviewed
Primary sources checked during evaluation.
Referenced in the comparison table and product reviews above.
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