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About ComplianceQuest
ComplianceQuest is the #1 AI-powered Quality, Risk, and Compliance (QRC) platform that connects Product, Quality, Manufacturing, People, Suppliers and Customers in a single system.
Built on Salesforce, the platform delivers end-to-end visibility, AI-driven intelligence, and enterprise-scale execution, enabling organizations to manage risk, ensure regulatory compliance, and turn quality into a driver of growth.
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The only AI-powered, Salesforce-native platform that unifies Quality Management, EHS, Supplier Quality, Product Lifecycle, and regulatory compliance for medical device manufacturers - across every global standard, in one connected system.
ONE PLATFORM · ALL MODULES · ZERO SILOS
Medical device manufacturers at enterprise scale operate under the most demanding quality obligations in any industry. Every design decision, supplier interaction, safety incident, complaint, and process change must be traceable, documented, and immediately defensible to regulators across multiple jurisdictions simultaneously.
The greatest risk isn't a specific regulation. It's the disconnected systems - siloed QMS, separate EHS tools, manual supplier tracking, paper-based training records - that make compliance invisible until an audit, a warning letter, or a recall makes the gaps catastrophic.
ComplianceQuest replaces fragmentation with one intelligent, connected platform built specifically for regulated manufacturers who cannot afford compliance gaps.
ComplianceQuest covers the full breadth of enterprise quality, safety, supplier, and product lifecycle management - all connected through a single data model, shared audit trail, and CQ.AI™ intelligence layer.
Complete validated eQMS pre-configured for ISO 13485:2016 and FDA QMSR. Closed-loop workflows connect complaints, NCs, CAPAs, audits, and documents in one system - with continuous inspection readiness built in.
21 CFR Part 11-compliant e-signatures, automated version control, and unified management of SOPs, work instructions, DHF, DMR, and DHR. Full document lifecycle from creation to obsolescence.
Structured corrective and preventive action with root cause analysis, eight disciplines (8D), FMEA-linked actions, and automatic effectiveness verification - linked to every upstream quality event.
Log, classify, investigate, and resolve nonconformances with MRB disposition workflows, CAPA initiation, and CQ.AI™ trend analytics that surface recurring failure patterns proactively.
Plan, schedule, execute, and close internal, external, and supplier audits. Digital evidence capture, automatic CAPA initiation from findings, and real-time audit dashboards for perpetual readiness.
ISO 14971-aligned risk assessment with hazard identification, risk evaluation, FMEA, and risk controls - linked directly to design control records, post-market surveillance, and product change events.
MDR-compliant complaint intake, investigation, and closure. Automatic regulatory reporting triggers for FDA MDR (21 CFR Part 803) and EU MDR vigilance (Article 87–90). Complaint trends feed directly into CAPA.
Controlled change request workflows for design changes, process changes, labeling changes, and supplier changes - with impact assessment, cross-functional review routing, and regulatory change notifications.
Role-based training assignment automatically triggered by document approvals and change events. Competency tracking, electronic acknowledgment, and real-time completion dashboards across multi-site teams.
Manage the full Design History File (DHF) with traceable links between user needs, design inputs/outputs, verification and validation, and risk controls. Supports 21 CFR 820.30 and ISO 13485 Clause 7.3.
Proactive PMS management including post-market surveillance plans (PMSP), PMSR, and PSUR reporting for EU MDR. Connected to complaint, vigilance, and CAPA workflows for a fully closed-loop PMS system.
Real-time quality dashboards built on Salesforce's analytics layer. CAPA cycle time, nonconformance trends, audit findings by site, supplier scorecards - all in configurable executive and operational views.
Unified environmental, health, and safety management for medical device manufacturing operations. Incident management, risk assessments, safety audits, OSHA and ISO 45001 compliance workflows - integrated with the QMS for a single safety and quality risk view.
Real-time incident reporting, root cause analysis, and corrective action tracking for workplace safety events. Automatic CAPA initiation from safety incidents - linked to quality workflows in the same system.
Dynamic workplace hazard identification, job safety analysis (JSA), and risk register management for manufacturing environments - with configurable risk scoring matrices and mitigation tracking.
Track and report on environmental performance metrics - emissions, waste, water, and energy usage - aligned with ISO 14001 and ESG reporting obligations. Proactively monitor your organisation's environmental impact.
Manage environmental and safety permits, regulatory obligations, and compliance calendars across your manufacturing sites - with automated renewal alerts and regulatory change tracking.
Digital safety audit workflows with mobile-enabled checklists, real-time evidence capture, and automatic corrective action initiation - integrated with the broader QMS audit module for consolidated compliance oversight.
ComplianceQuest's dedicated supplier collaboration portal. PartnerQuest enables medical device manufacturers to qualify suppliers, share quality requirements, manage SCARs, receive real-time performance data, and collaborate on corrective actions - all in one FDA and ISO 13485-compliant system.
Structured onboarding and qualification workflows for new suppliers - including questionnaires, document collection, capability assessments, and approved vendor list (AVL) management aligned with ISO 13485 Clause 7.4.
Real-time supplier scorecards tracking quality, delivery, and responsiveness. Automatic re-qualification triggers based on configurable performance thresholds. Predictive analytics flag at-risk suppliers before disruptions occur.
Plan and execute supplier audits with digital evidence capture, CAPA initiation from findings, and automated follow-up tracking. Supplier audit records are fully linked to the QMS audit module for consolidated oversight.
Issue, track, and close supplier corrective action requests with structured root cause analysis, action plans, effectiveness verification, and automatic escalation if supplier response timelines are breached.
Manage incoming supplier change notifications with structured impact assessment workflows - ensuring that supplier-initiated changes to materials, components, or processes are evaluated against your quality requirements before approval.
ProductQuest - ComplianceQuest's integrated PLM module - connects product design, engineering change, bill of materials, and production documentation directly to the QMS. Quality and design data share a single platform, eliminating the handoffs that slow product development and create compliance gaps.
Manage the complete design history file (DHF) with ISO 13485 and QMSR-aligned design controls. Traceable links between user needs, design inputs, design outputs, verification, validation, and risk - in one place.
Maintain a detailed, version-controlled inventory of parts, assemblies, and materials required for device manufacturing - linked to engineering change control and supplier quality records for end-to-end traceability.
Structured engineering change request workflows with impact assessment across BOM, documentation, risk, and regulatory records - ensuring all device changes are evaluated, approved, and traceable before implementation.
Manage IQ, OQ, and PQ protocols, test records, and validation reports within the QMS - directly linked to design outputs and risk controls. Supports 21 CFR Part 11 and computer system validation (CSV) requirements.
Manage Unique Device Identifier (UDI) compliance, labeling records, and GUDID/EUDAMED submissions within a controlled document management environment - connected to change control and regulatory affairs workflows.
ComplianceQuest's AI engine — trained on over 5 million inspections and 2 million documents from regulated industries — powers intelligent automation across every module. CQ.AI™ is not a generic LLM wrapper; it is purpose-built quality intelligence with domain-specific regulatory training that no competitor can replicate at this scale.
CQ.AI™ analyses nonconformance patterns, identifies emerging failure trends, and alerts quality teams before issues escalate to CAPAs, recalls, or regulatory findings. Act on intelligence, not hindsight.
AI-powered deviation identification across audit findings, complaint data, and production records — automatically flags duplicate events, cross-references root causes, and suggests applicable CAPA actions.
CQ.AI™ agents read, summarise, and cross-reference quality records — dramatically reducing the time quality managers spend reviewing documents during audits, investigations, and management reviews.
Generate device-specific ideas for design controls and risk identification. CQ.AI™ assists engineering teams in building comprehensive design history files faster — with AI-suggested traceability links and gap detection.
Proactive recall risk scoring based on complaint trends, field safety signals, and production quality events — enabling quality leadership to identify and mitigate recall risk before it reaches the patient or the regulator.
ComplianceQuest is pre-configured for the full spectrum of global standards governing medical devices - so your team configures once and maintains continuous compliance across all jurisdictions, simultaneously.
The FDA's QMSR (effective February 2026) harmonises 21 CFR Part 820 with ISO 13485. CQ is already QMSR-ready - zero re-implementation required for current users.
The international benchmark for medical device quality management. All CQ workflows are mapped to ISO 13485 clauses - from design control through post-market surveillance.
Full EU MDR and IVDR compliance - post-market surveillance plans, vigilance reporting, EUDAMED integration readiness, and technical documentation management aligned with Annex II/III.
One CQ audit cycle supports MDSAP requirements across five regulatory authorities - reducing multi-authority audit burden for global manufacturers.
UK Conformity Assessment (UKCA) requirements, MHRA vigilance reporting, and UK-specific technical documentation controls - managed in the same platform as EU and US compliance.
CMDR compliance workflows for device licence applications, quality system certification under ISO 13485 (mandatory in Canada since 2019), and mandatory problem reporting obligations.
CQ supports the emerging regulatory framework for SaMD, including FDA Predetermined Change Control Plans (PCCP), IEC 62304 lifecycle requirements, cybersecurity documentation, and IMDRF SaMD guidance.
Occupational health and safety management (ISO 45001) and environmental management (ISO 14001) workflows fully integrated with the QMS - delivering a unified QHSE compliance platform for medical device manufacturers.
From initial concept through post-market surveillance - CQ provides the tools, traceability, and compliance workflows your team needs at every stage.
At enterprise scale, your mandate goes beyond maintaining compliance. It is to make quality a measurable strategic advantage. ComplianceQuest delivers real-time visibility, cross-functional control, and executive-ready reporting that turns quality data into business intelligence — so you lead quality strategy, not audit responses.
Quality managers at 500+ employee medical device companies spend too much time chasing approvals, compiling evidence, and tracking CAPA status manually. ComplianceQuest automates these workflows so your expertise is directed at solving quality problems — not managing paper trails across disconnected systems.
Design controls, risk management, engineering change, and V&V are engineering functions, not just quality functions. ComplianceQuest's PLM and design control capabilities connect your engineering workflows directly to the QMS, eliminating the manual handoffs that delay product development and create compliance gaps at submission.
For medical device manufacturers, supplier quality is not a QMS afterthought — it is a direct patient safety and regulatory obligation. PartnerQuest gives procurement leaders the tools to qualify, monitor, and manage suppliers with the rigour that FDA, ISO 13485 Clause 7.4, and post-market surveillance requirements demand — without slowing sourcing decisions.
ComplianceQuest uniquely unifies post-market patient safety obligations (EU MDR vigilance, FDA MDR reporting, FSCA management) with occupational health and safety management (ISO 45001, OSHA) in one platform. Safety incidents, quality events, and compliance obligations are connected through a shared closed-loop workflow — not managed in siloed tools.
The QMS platform you choose today determines whether quality becomes a growth enabler or a growth bottleneck as you scale from Series A to global commercialisation. ComplianceQuest delivers enterprise-grade capability from day one — with the flexibility to expand across modules, sites, and user counts without re-implementation.
Greenlight Guru serves medtech SMBs. MasterControl offers standalone eQMS. ComplianceQuest is the only enterprise platform that integrates QMS, EHS, PLM, and Supplier Quality — with AI intelligence — in one Salesforce-native system.
Trained on 5 million+ inspections and 2 million+ documents from regulated industries, CQ.AI™ delivers predictive nonconformance trend analysis, automatic deviation detection, recall risk scoring, and intelligent document summarisation. This is purpose-built regulatory AI — not a generic chatbot with a compliance label.
Built natively on Salesforce — the platform trusted by most Fortune 500 companies. Single sign-on, enterprise security, global data residency, and seamless integration with SAP, Oracle, Microsoft Dynamics, and any modern ERP or MES system. No custom middleware. No data sync delays. No separate login.
Pre-configured for ISO 13485, FDA QMSR, EU MDR, UKCA, Health Canada, MDSAP, ISO 45001, and ISO 14001 simultaneously — in a single system instance. Critical for enterprise manufacturers in the US, UK, Germany, France, Spain, Italy, and Canada managing multi-market compliance from one platform.
QMS, EHS, Supplier Quality, and PLM share one data model, one audit trail, one reporting layer, and one AI engine. When a complaint triggers a CAPA triggers a supplier corrective action triggers an engineering change — CQ tracks the entire thread automatically. No exports. No data reconciliation. No gaps in traceability.
Every link below is a dedicated resource covering a specific solution, compliance standard, or role — built to answer your exact questions.
Clause-by-clause audit checklist with evidence prompts used by 10,000+ medical device quality professionals globally. Free download.
Practical steps for aligning your existing quality system with the FDA's new QMSR before the February 2026 enforcement date.
Validated CAPA template covering root cause analysis, corrective action plan, implementation evidence, and effectiveness verification.
On-demand webinar on EU MDR Article 83–86 PMS obligations — including common notified body findings and practical guidance.
ComplianceQuest offers a comprehensive suite covering the full breadth of enterprise quality, safety, and operational management for medical device manufacturers: Quality Management System (QMS) including document management, CAPA, audit management, risk management, complaint management, nonconformance management, change management, design control, and training management; Environmental Health & Safety (EHS) including incident management, safety audits, risk assessments, and environmental sustainability; Supplier Quality Management through PartnerQuest including supplier qualification, performance management, SCARs, and supplier audits; and Product Lifecycle Management (PLM) through ProductQuest covering design controls, engineering change, BOM management, and V&V.
All modules run on a single Salesforce-native platform, sharing one data model and one AI engine (CQ.AI™) — so every module is connected and every quality event is traceable across the entire platform without manual data transfer or system integrations.
ComplianceQuest supports the full spectrum of global medical device regulatory standards simultaneously in one platform: ISO 13485:2016 (global QMS standard), FDA Quality Management System Regulation (QMSR, effective February 2026), 21 CFR Part 820 (legacy US QSR), 21 CFR Part 11 (electronic records and signatures), 21 CFR Part 803 (Medical Device Reporting), EU MDR 2017/745, EU IVDR 2017/746, ISO 14971:2019 (risk management), MDSAP (covering FDA, Health Canada, TGA, ANVISA, and PMDA), UKCA/MHRA (United Kingdom), Health Canada CMDR, ISO 45001 (occupational health and safety), ISO 14001 (environmental management), IEC 62304 (Software as a Medical Device), and the FDA's evolving framework for AI/ML-enabled devices including Predetermined Change Control Plans (PCCP).
This multi-jurisdiction coverage means manufacturers operating across the US, EU, UK, and Canada manage all compliance obligations within a single system instance — without separate platforms per market.
Greenlight Guru is purpose-built for medtech companies but primarily targets startups and growth-stage organisations, with limited scalability for complex multi-site enterprise operations and no built-in EHS or PLM capabilities. MasterControl offers a standalone eQMS with strong document and training modules but operates as a closed ecosystem without native Salesforce integration, AI intelligence at scale, or unified supplier quality and EHS management.
ComplianceQuest is the enterprise choice for 500+ employee medical device manufacturers because it delivers QMS, EHS, Supplier Quality, and PLM in one Salesforce-native platform with CQ.AI™ trained on 5 million+ inspections. It supports simultaneous compliance across all global regulatory frameworks (FDA QMSR, ISO 13485, EU MDR, UKCA, Health Canada) in a single system — something neither Greenlight Guru nor MasterControl can match at enterprise scale.
Yes. The FDA's Quality Management System Regulation (QMSR) became effective in February 2026 and harmonises 21 CFR Part 820 with ISO 13485:2016 — creating a significant compliance gap for manufacturers using legacy 820-based systems. ComplianceQuest is already QMSR-ready because its workflows are built on ISO 13485 from the ground up.
CQ specifically supports the new QMSR requirements including the Medical Device File (MDF) concept (replacing the DHF structure), updated design control traceability expectations, revised supplier oversight obligations under the harmonised framework, and strengthened CAPA and risk-based quality decision-making requirements. Current CQ users face no re-implementation to achieve QMSR compliance.
ComplianceQuest provides a complete EU MDR post-market surveillance (PMS) management capability including post-market surveillance plan (PMSP) creation and management, periodic safety update report (PSUR) and post-market surveillance report (PMSR) management, vigilance reporting workflows aligned with EU MDR Articles 87–92, field safety corrective action (FSCA) and field safety notice (FSN) management, and integration between PMS data, complaint management, and CAPA workflows.
The platform also supports EUDAMED registration readiness and connects post-market safety signals detected by CQ.AI™ directly into the quality and safety closed-loop — so no signal detected in complaints or field incidents is lost before appropriate regulatory reporting obligations are triggered.
CQ.AI™ is ComplianceQuest's purpose-built AI intelligence engine, trained on over 5 million inspections and 2 million quality documents from regulated industries. Unlike generic AI tools applied to quality management, CQ.AI™ has domain-specific regulatory training that enables it to provide meaningful intelligence across the full quality lifecycle.
For medical device teams specifically, CQ.AI™ delivers predictive nonconformance trend analysis (identifying recurring failure patterns before they escalate to CAPAs or recalls), automatic deviation detection and deduplication across quality events, design control AI assistance (generating device-specific design input and risk suggestions), intelligent document summarisation to reduce audit preparation time, safety signal detection from complaint and field incident data, and recall risk scoring based on production and post-market quality signals. CQ.AI™ is available across all platform modules — not limited to a single quality process.
ComplianceQuest supports the regulatory requirements for Software as a Medical Device (SaMD) and AI/ML-enabled devices through its PLM and design control modules. This includes IEC 62304 software lifecycle management (software development planning, architecture, unit implementation, testing, and maintenance), FDA Predetermined Change Control Plan (PCCP) documentation for AI/ML-enabled devices, cybersecurity documentation management aligned with FDA's 2025 premarket cybersecurity guidance, and IMDRF SaMD guidance framework support.
CQ also supports the software validation requirements of 21 CFR Part 11 and provides IQ/OQ/PQ documentation packages for the validation of CQ itself as a regulated software system — which is particularly important for manufacturers implementing a new digital QMS in an FDA or EU MDR-regulated environment.
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