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Middle Office Platform
The only AI-powered Middle Office Platform that unifies PLM, QMS, EHS, and SRM into a single, intelligent solution
ProductQuest
Product Lifecycle Management
Design Quality
Design Process and Quality System Development Tools in Product Lifecycle
Design Quality: Connecting Design to Documentation
QualityQuest
Complaints Management
Documents and Learning Management
Quality Management
Risk Management
Challenges with Triage and Investigation in Complaints Management Process
Manufacturing Challenges and Industry Trends Towards Digital Transformation
Frost Radar for Quality Management Systems Names ComplianceQuest Leader
Automation of the Risk Management Lifecycle with AI and Analytics
PartnerQuest
Supplier Management
The Ultimate Guide to Next-Generation Supplier Management [e-Book]
SafetyQuest
Safety Management
Environment and Sustainability
Safety Essentials: Key ‘Must-have’ Components for Safety Management at Any Enterprise
Environmental & Sustainability Management
Transform quality into an enabler: boost efficiency, increase satisfaction, and trim costs with a fully connected, AI-powered quality management solution
Enable risk-based thinking throughout your quality processes with a fully integrated risk management solution
Increase supplier performance, reduce costs, and streamline your supply chain with integrated supplier quality and collaboration tools
Identify and minimize safety events. Prevent accidents, safeguard workers, and ensure their well-being and health
Proactively and accurately monitor and measure your company’s impact on the environment to improve performance and reach your environmental and sustainability targets
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ComplianceQuest covers the whole spectrum of customers, industries and regions across the world. Whether it is a small, medium or enterprise sized manufacturer, companies choose ComplianceQuest for its end-to-end Product Lifecycle, Quality, Safety and Supplier Management Solutions.
Salesforce
Leveraging AI to Create a Safer Workplace Environment
Why an EHS Solution Built on Salesforce Works Better Than One Built on AWS or Azure
CQ Platform
Humans: The Real Superheroes of Artificial Intelligence (AI) in Quality Management
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Featured Case Study
ComplianceQuest Medical Devices QMS Success Stories eBook
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Complaint Handling Process for MedTech and Life Science Companies
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Unlocking the Value of Complaints
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Why You Need to Digitally Transform Your QMS
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Compliance
The Ultimate Guide to ISO/IEC 17025:2017 Compliance
Infographic
Safety Technology Trends to Watch in 2023 (Infographic)
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Featured Toolkit
Data-driven Safety – Strategic Resources for Monitoring of Key Performance Indicators
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Lean and Six Sigma Conference
22 Feb, 2026
Phoenix, AZ
About
About ComplianceQuest
Transform to a fully connected business with a next-generation AI-powered Product Lifecycle, Quality, Safety, and Supplier management platform, built on Salesforce.
Our connected suite of solutions helps businesses of all sizes increase quality, safety and efficiency as they bring their products from concept to customer success.
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Implementing a robust EQMS will help automate the transition from EUDAMED and related processes
On May 26, 2022, In Vitro Diagnostic Directive (IVDD) will be replaced by In Vitro Diagnostic Medical Device Regulation (IVDR), introducing a new approach to how in vitro diagnostic devices (IVDs) will be regulated in the European Union (EU). In Vitro Diagnostic Medical Device Regulation (IVDR) replaces the previous IVD directives to enable reliable and effective IVDs. The amended directives include regulatory changes and requirements to enhance the safety and efficacy of IVDs for non-EU manufacturers and economic operators with commercial operations in the European Economic Area (EEA).
Article 10 of IVDR mandates a quality management system to ensure that manufacturing, change control, customer complaints, resource management, supplier and subcontractor controls and validation, performance evaluation, quality test, UDI labeling, post-market surveillance, etc. are according to the approved QMS and Post-Market Surveillance (PMS) plans. Implementing a pre-validated Enterprise Quality Management System (EQMS) will undoubtedly make life easier for quality leaders who are gearing up to meet the stringent and complex requirements of IVDR.
In the fast-evolving landscape of medical devices, particularly for in vitro diagnostic devices (IVDs), staying compliant with stringent regulations is…
On May 26, 2022, In Vitro Diagnostic Directive (IVDD) will be replaced by In Vitro Diagnostic Medical Device Regulation (IVDR),…
The European Commission’s In Vitro Diagnostic Regulation (EU IVDR 2017/746), which is going to be effective from 26 May 2022,…
Provide visibility between your quality processes, product record, requirements, issues, and related processes
Enable teams to confirm designs easily, adjust plans, and resolve issues fast
Quickly find the root cause and speed up resolution
Predictive analysis of data reduces the risk of probable quality failure
Limit damages to profits, reputation, and existing relationships
We conducted a thorough, comparative review of systems within our budget and CQ was a clear winner. The system is powerful and versatile, even with an out of box implementation. The functionality is complete, covering every significant aspect of a quality system. Validation is straightforward with the use of OQ scripts from CQ, which can be modified to fit your implementation. It ensures that processes implemented through the system and records generated by the system are compliant for medical device companies. But, the biggest benefit we’ve received is through the collaborative partnership with CQ personnel. They listen and understand our needs. They are creative in helping us make implementation as easy as possible. Having been in large companies and small, I can see this system fitting in either environment and budget.
Jackie Jaskula,Director of QA and Regulatory
For a successful outcome, manufacturers, including economic operators (Importers, Authorized Representatives, Distributors) must work closely and cooperate with the Notified Bodies, suppliers, and sub-contractors of the European Commission and Competent Authorities to ensure the legislative framework is successfully adopted, and safe products are continually available to the patients in need.
ComplianceQuest’s EQMS solution is designed to manage the entire product lifecycle right from well-established technical documentation, procedures, document management, change control, design control, CAPA, etc. This can help meet IVDR requirements more intuitively and enable automating the various quality areas, assisting auditors in evaluating the process, data quality, and integrity.
Some of the ComplianceQuest EQMS’s features that facilitate IVDR transition include:
Cloud-Based System
A next-generation, cloud-based EQMS like ComplianceQuest will make it easy to ensure people, processes, and systems are genuinely connected. It will help enhance productivity, streamline collaboration, and ensure seamless flow of information across the organization. ComplianceQuest’s cloud-based EQMS provides real-time data analysis and updates that play a crucial role in being 24/7 audit-ready.
Digital Change Management
Unless QMS documentation is digitally managed, change management will be erroneous or would lack updating. ComplianceQuest Document Management Solution enables you to manage the entire document lifecycle and gain complete visibility as you transition to IVDR. With an electronic approach to document management, leaders responsible for this transition to IVDR will have a central repository to create, modify, review, approve, store, organize, access, and share documents globally in a controlled manner.
Suppliers and Sub-Contractor Controls
IVD manufacturers depend on various suppliers to produce and deliver safe, accurate, and effective products for human use. Thus, regulatory and quality concerns are also evolving when it comes to suppliers and subcontractors. Convey the IVDR requirements to the suppliers and ensure new agreements are in place. ComplianceQuest Supplier management solution offers supplier and sub-contractor controls and validation helps avoid the risk of IVDR noncompliance.
Post-Market Surveillance and Vigilance
Manufacturers are required to produce the PMS Plan and Report/Periodic Safety Update Report (PSUR) following the IVDR. A procedure to perform PMS and vigilance should be in place, and it should be continuously updated. A robust and reliable quality management system (QMS) such as the one from ComplianceQuest allows users to have a post-market performance follow up plan.
Internal and External Communication
Real-time communication with quantifiable data within and external to the organization is essential. Our QMS module is equipped with effortless communication channel while the system is available on mobile. This facility helps communicate the whole process to all the suppliers, sub-contractors, or service providers and their obligations.
Suppliers And Sub-Contractor Controls
Post-Market Surveillance And Vigilance
Internal And External Communication
IVDD to IVDR – Strategic Planning & Assessment
Checklist | June 8th, 2021
IVDR Preparedness Assessment Checklist
Suppliers Activities Impacting Manufacturer Regulatory Compliance (EU IVDR): in-vitro diagnostic
Checklist | October 4th, 2021
Importer(s)’ Obligations Under EU IVDR
Checklist | September 27th, 2021
Essential Responsibilities of Distributor(s) Under EU IVDR
Does your post-market surveillance (PMS) plan address the current regulatory requirements (IVDR)? [Checklist]
Checklist | August 20th, 2021
In this blog, we emphasize the importance of building a strong foundation with a robust supplier information system that ensures…
A couple of months ago, at ComplianceQuest, we published a…
Just recently, at ComplianceQuest, we published a blog titled ‘Supplier Metrics:…
Every manufacturer faces a unique set of challenges: supply chain…
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