Join ConQuest 2025 | ComplianceQuest User Conference | April 8–10, Clearwater Beach, FL
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Enable cross-functional collaboration and accelerate your product lifecycle with a cloud-based platform for innovation
Design Process and Quality System Development Tools in Product Lifecycle
Get full visibility over your product design processes and make collaboration easy to get your products to market faster, compliantly
Design Quality: Connecting Design to Documentation
Transform customer complaints to valuable sources of insights for continuous improvement through smart automations and integrated regulatory reporting
Challenges with Triage and Investigation in Complaints Management Process
Say goodbye to paper! Modernize your processes with connected document, training, and change management
Manufacturing Challenges and Industry Trends Towards Digital Transformation
Transform quality into an enabler: boost efficiency, increase satisfaction, and trim costs with a fully connected, AI-powered quality management solution
Frost Radar for Quality Management Systems Names ComplianceQuest Leader
Enable risk-based thinking throughout your quality processes with a fully integrated risk management solution
Automation of the Risk Management Lifecycle with AI and Analytics
Increase supplier performance, reduce costs, and streamline your supply chain with integrated supplier quality and collaboration tools
The Ultimate Guide to Next-Generation Supplier Management [e-Book]
Identify and minimize safety events. Prevent accidents, safeguard workers, and ensure their well-being and health
Safety Essentials: Key ‘Must-have’ Components for Safety Management at Any Enterprise
Proactively and accurately monitor and measure your company’s impact on the environment to improve performance and reach your environmental and sustainability targets
Environmental & Sustainability Management
Electronic and Automated Approach to Audit Management
Managing the Tools of the Trade
Manage Operational Risk Tracking, Evaluation, Mitigation and monitoring
Leveraging CAPA for Continuous Improvement
Ensure your laboratory is compliant with systematic and efficient laboratory investigations
Incident Reporting and Management
Organization, Collaboration and Governance for Efficient Changes
Conduct smart management review meetings with a tower of data to improve your quality and safety systems
Gain 360 degree vision into enterprise wide Safety risks
Enhance Safety and Compliance with Smarter Chemical Management
Ensuring Quality across Departments & Locations
Partner With Suppliers And Vendors To Improve Quality And Safety
Create Loyalty by Addressing Customer Complaints Smartly
Bring Consistency to Permit Practices
Make it easy for your people to manage, track and analyze environmental and sustainability metrics
Bring higher quality products to market quicker with design controls, projects & DHF
Streamline Permit Management and Ensure Compliance
When Learning Propels Organizational Growth
Improve efficiency, productivity, and compliance with a solution designed for today's diverse workforce learning styles
Strategically manage the complete lifecycle of your product
Efficient Waste Management for Compliance & Sustainability
Relevant Information within reach - Always.
Assuring Quality Products and Services
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.
Leveraging AI to Create a Safer Workplace Environment
Why an EHS Solution Built on Salesforce Works Better Than One Built on AWS or Azure
Humans: The Real Superheroes of Artificial Intelligence (AI) in Quality Management
ComplianceQuest Medical Devices QMS Success Stories eBook
Complaint Handling Process for MedTech and Life Science Companies
Audit Management
Aphria (now Tilray) CIO talks about their implementation of ComplianceQuest, Rootstock and Salesforce
Unlocking the Value of Complaints
Why You Need to Digitally Transform Your QMS
The Ultimate Guide to ISO/IEC 17025:2017 Compliance
Safety Technology Trends to Watch in 2023 (Infographic)
Data-driven Safety – Strategic Resources for Monitoring of Key Performance Indicators
American Society of Quality Lean Six Sigma Conference
23 Feb, 2025
Phoenix, AZ
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 product, quality, safety, and supplier as they bring their products from concept to customer success.
Where Your Career Takes Flight: Join our dynamic team and be part of an innovative, collaborative and rewarding workplace culture.
Impact Through Action: How the ComplianceQuest team supports social causes and community engagement
The Pulse of ComplienceQuest: Our newsroom shares stories of innovation, progress, and change
Stronger Together: How our partnerships drive success and innovation
Today’s competitive business environment has placed tremendous pressure on medical devices manufacturing companies to lower operating costs, address complex product design, outsource development and seek global expansion plans. Beyond this pressure there is major opportunity for companies to build a competitive advantage through an integrated risk and compliance management approach that ensures all features are working together effectively, enabling superior visibility into the value chain.
ISO for Medical Devices manufacturing processes and supply chain management that were once easy to handle are now much more complex. What used to be controlled and contained within the manufacturing plant is now monitored, run and maintained globally. Given this situation, building an effective risk and quality compliance system that conforms to management standards like ISO 13485 and ISO 9000 among others, is imperative for companies that want to work efficiently and succeed over smarter customers.
The medical device sector is highly regulated worldwide due to the direct impact these products have on patient health and…
ISO 13485 is a regulatory requirement specifically applicable to medical device manufacturers. It is based on ISO 9001:2015 and is…
In 2018, the US FDA had announced its plans to harmonize FDA Quality System Regulations (QSR) with ISO 13485:2016 quality…
ISO 13485 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. The primary objective is to facilitate ISO 13485 medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9000 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems follows all the requirements of ISO 9001. All requirements of ISO for medical devices are specific to organizations, regardless of the type or size of the organization.
ComplianceQuest – Enterprise Compliance and Quality Management Software (EQMS) is an integrated cloud based ISO 13485 software solution that goes above and beyond the requirements for ISO 13845 while automating your entire quality management system requirements. CQ significantly reduces the effort involved in maintaining your ISO 13485 Quality System by building the required processes to be automated while maintaining full traceability. Imagine, the time and money your company can save with an intuitive web based system, which will replace all the hard copies, and those random word and excel files. CQ was designed from the ground-up to be not only extremely user friendly at all levels but provide for a very powerful platform to scale from a small company to a large global enterprise. CQ helps you organize your company’s ISO requirements improving productivity while easily helping the auditors to find what they need quickly and effortlessly.
Customer Success
International Organization for Standardization (ISO) standards play a crucial role in regulating the quality and safety of medical devices globally. These ISO standards are implemented and followed to ensure that medical devices are designed, manufactured, and distributed with a strong emphasis on quality, safety, and regulatory compliance, ultimately benefiting patients and healthcare providers. ISO for medical devices provide a framework for manufacturers to ensure their devices meet specific requirements, adhere to regulations, and prioritize patient safety.
We have implemented CQ in a new medical device start up. The set up and implementation went very smooth and the support from the provider has been outstanding. The system fully supports compliance with ISO 13485.
Some of the reasons why I would recommend the software are: – 100% cloud-based – Allow almost paperless Quality Management System – Excellent customer support – Simple set up and implementation – User friendly – Efficiency and security – Accessible cost for small companies.
Laura Granados,QMS Systems Development Consultant
Is Your Internal Communication Related to QMS (ISO 13485) Adequate?
Checklist | September 27th, 2021
“Records” to be Maintained for an ISO 13485 Certified Device Manufacturer
Checklist | May 28th, 2021
Medical Device Software Lifecycle Processes Checklist (Part 1)
Checklist | August 5th, 2021
Medical Device Software Lifecycle Processes Checklist (Part 2)
‘Medical Device’ is a terminology used for a wide variety of ‘devices’ associated with the treatment or therapy of a…
ComplianceQuest’s modern, cloud-based, AI-driven EQMS solution built on the Salesforce…
The International Medical Device Regulators Forum (IMDRF) defines Software as…
Today’s competitive business environment has placed tremendous pressure on medical…
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