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The only AI-powered Middle Office Platform that unifies PLM, QMS, EHS, and SRM into a single, intelligent solution
Product Lifecycle Management
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
Design Quality
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
Complaints Management
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
Document and Learning Management
Say goodbye to paper! Modernize your processes with connected document, training, and change management
Manufacturing Challenges and Industry Trends Towards Digital Transformation
Quality Management
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
Risk Management
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
Supplier Management
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]
Safety Management
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
Environment and Sustainability
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
Self-guided Product Tours
Product Demo Videos
Pricing
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
Recent Blogs
Recent Infographics
Recent Case Studies
Featured Case Study
ComplianceQuest Medical Devices QMS Success Stories eBook
Recent Checklists
Featured Checklist
Complaint Handling Process for MedTech and Life Science Companies
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Recent CQ Guides
Featured CQ Guide
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Podcast
Aphria (now Tilray) CIO talks about their implementation of ComplianceQuest, Rootstock and Salesforce
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Recent Webinars
Webinar
Unlocking the Value of Complaints
Recent Whitepapers
Whitepaper
Why You Need to Digitally Transform Your QMS
Recent Compliance
Compliance
The Ultimate Guide to ISO/IEC 17025:2017 Compliance
Infographic
Safety Technology Trends to Watch in 2023 (Infographic)
Recent Toolkits
Featured Toolkit
Data-driven Safety – Strategic Resources for Monitoring of Key Performance Indicators
Events and Webinars
Events
Upcoming Webinars
Featured Event
American Society on Quality World Conference on Quality and Improvement
04 May, 2025
Denver, CO
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 product, quality, safety, and supplier as they bring their products from concept to customer success.
Meet the Leadership Team
Careers
Where Your Career Takes Flight: Join our dynamic team and be part of an innovative, collaborative and rewarding workplace culture.
Corporate Citizenship
Impact Through Action: How the ComplianceQuest team supports social causes and community engagement
Customers & Testimonials
Newsroom
The Pulse of ComplienceQuest: Our newsroom shares stories of innovation, progress, and change
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Stronger Together: How our partnerships drive success and innovation
Upcoming Events
In the current era, the life sciences sector is experiencing an unprecedented wave of regulatory changes that impact organizations involved in pharmaceuticals, medical devices, and in-vitro diagnostics. The Medical Device Regulation (MDR) has emerged as a robust, transparent, predictable, and sustainable regulatory framework, ensuring the production and supply of high-quality and safe medical devices within Europe.
The MDR sets the stage for an improved landscape regarding quality and safety standards for medical devices. Its implementation ensures higher scrutiny, transparency, and accountability, ultimately benefiting patients and fostering innovation in the medical device industry.
The MDR introduces new guidelines to create an advanced and refined landscape for medical device quality and safety to achieve this goal. These guidelines include:
The Medical Device Regulation (MDR) brings several significant changes compared to the previous regulatory framework. Some of the key changes include:
MDR imposes various important requirements for medical devices, such as,
Notified Bodies play a crucial role in implementing the Medical Device Regulation (MDR). Their primary role involves assessing and certifying the conformity of medical devices with the regulatory requirements outlined in the MDR. These bodies, designated by EU member states, act as independent third-party organizations responsible for conducting conformity assessment procedures.
Notified Bodies have several key responsibilities. They evaluate the technical documentation manufacturers provide to ensure compliance with MDR requirements. Upon successful evaluation, they issue a certificate of conformity, indicating that the medical device meets the MDR’s essential safety and performance requirements. Notified Bodies also conduct ongoing surveillance activities, such as audits and inspections, to ensure the continued compliance of certified devices. They contribute to post-market surveillance by monitoring devices in the market and reporting any adverse incidents or non-compliance issues to competent authorities. Additionally, they provide manufacturers with expert advice and guidance throughout the certification process, helping them navigate the regulatory landscape and meet the necessary requirements.
Post-Market Surveillance (PMS) and vigilance are essential components of MDR. PMS and vigilance ensure the ongoing safety and performance of medical devices in the market, allowing for timely identification and mitigation of any potential risks or issues that may arise after the devices are placed on the market.
The key aspects of PMS and vigilance include:
Changes impacting In Vitro Diagnostic (IVD) devices help to enhance the safety, reliability, and effectiveness of IVD devices, ensuring their proper regulation and monitoring throughout their lifecycle.
Some of the key changes include:
Understanding and complying with MDR can help ensure medical devices’ safety and effectiveness, maintain market access, protect their reputation, and contribute to improving patient care. Here are key reasons why understanding and complying with the MDR is critical:
ComplianceQuest offers QHSE solutions specifically designed for Medical Devices & Diagnostics companies, enabling them to effectively maintain product quality, safety, and compliance with regulatory standards and internal SOPs. By automating the entire quality management system, the ComplianceQuest EQMS solution ensures adherence to ISO requirements and best practices while providing comprehensive traceability. The platform streamlines MDR requirements, enhancing productivity and facilitating quick and effortless access for auditors and notified bodies. Additionally, ComplianceQuest assists medical device companies in reducing compliance costs while fully meeting FDA regulations.
To know more about how ComplianceQuest can create a new and improved landscape for the Quality and Safety of the medical device complying with EU MDR, request a demo now:https://www.compliancequest.com/online-demo/
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