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
ISO 13485 standard is an effective solution to meet the comprehensive requirements for a Quality Management System (QMS). It provides a practical foundation for medical device companies to address Medical Device Directives, regulations and responsibilities as well as demonstrating a commitment to the safety and quality of medical device products. ISO 13485 QMS adapts the ISO 9001 process model of Plan, Do, Check, Act designed for regulatory compliance and is more prescriptive by requiring a more demanding quality management system and documentation.
In today’s competitive business environment operating internationally or expanding locally, companies with an ISO 13485 certification communicate a quality commitment to both customers and regulators. It allows increasing access to more markets worldwide, provides a mechanism on how to review processes across your organization for continuous improvement, and can increase efficiency, cut costs and improve your supply chain performance.
In 2016, ISO 13485 was updated to reflect general concerns, the need for clarity within the standard and to serve as a harmonized QMS model to be used by national and regulatory bodies. ISO 13485:2016 has increased focus on product realization planning, training “competency,” integration of QMS software, harmonization across other country laws, etc. and integrates “risk” throughout the QMS including supplier controls, change management, and product lifecycle for risk-based decision-making.
An internationally accepted standard by the FDA and other countries, ISO 13485:2016 is increasingly being required or at least beneficial in supporting regulations around the world, including Health Canada Canadian Medical Device Regulations CMDCAS program. In the absence of another update specific to the EU, CEN/TR 17223:2018 was introduced to provide the guidance on the relationship between EN ISO 13485:2016 and the new MDR (EU 2017/745) and IVDR (EU 2017/746) regulations which entered into force in May 2018. In addition, ISO 13485:2016 has become the backbone of the MDSAP (Medical Device Single Audit Program) with its integration in 2019.
ISO 13485:2016 has become the new foundation for medical device quality systems. If you haven’t started your gap analysis, the time to start that transition is now. It is critical for medical device manufacturers and suppliers to begin implementing the standards of the revised ISO 13485:2016, as the allotted three-year changeover period may not provide adequate time for all organizations to transition. ComplianceQuest can help as a solution for companies to effectively plan, monitor and improve overall quality management.
ComplianceQuest Modern Cloud Enterprise Quality Management System (EQMS) supports the latest edition of ISO 13485:2016 by automating your entire quality management system requirements while maintaining full traceability. CQ’s EQMS Suite was designed from the ground-up to be not only extremely user-friendly at all levels but also provide a very powerful platform to scale from small companies to large global enterprises. ComplianceQuest helps you organize your company’s ISO 13485:2016 requirements improving productivity while easily helping auditors and notified bodies to find what they need quickly and effortlessly.
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
Review and Update Your QMS with 50 Mandatory SOPs as per ISO 13485:2016
Checklist | April 7th, 2021
Standard BioTools Dramatically Cut Processing Time and Steps with Agile, Customizable Modules
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