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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
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When Learning Propels Organizational Growth
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Efficient Waste Management for Compliance & Sustainability
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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
On January 31, 2024, the US Food and Drug Administration announced an amendment to 21 CFR 820 concerning current good manufacturing practice (CGMP) for device manufacturing as part of its efforts to harmonize its regulations with other regulatory authorities. This amendment aligns more closely with the International Organization for Standardization, ISO 13485:2016, which is very similar to QS regulation in assuring the safe and effective manufacturing of devices. It will also ensure that the quality management system remains compliant with the Federal Food, Drug, and Cosmetic Act (FD&C Act).
The title of the regulation has been amended as Quality Management System Regulation (QMSR) to reflect the additional requirements that match the ISO 13485 concepts and expectations. The amendment made to part 4 (21 CFR part 4) will not create inconsistencies with other applicable regulations or impact the CGMP requirements for combination products.
As part of the harmonization efforts, the FDA has been doing the following:
The rule will become effective in two years, on February 2, 2026. The device manufacturers will be required to comply with the existing QS regulation for the time being but start preparing for the new requirements when they become effective.
Some of the key requirements of the new QMSR include:
Some of the key areas where the QMSR implementation will need work for manufacturers of medical devices include:
The standard increases the emphasis on risk identification, analysis, evaluation, control, and monitoring throughout the product life cycle to ensure the safety and effectiveness of the devices. A risk-based approach must be adopted through the product life cycle, right from design, development, traceability, purchase, and testing to installation and servicing.
The communication SOP to customers regarding the correction or removal of products must comply with 21 CFR Part 806 Medical Devices.
Design controls must be applied to class II, class III, and certain class I devices. It requires a review of any individual(s) who do not have direct responsibility for the design stage reviewing the design.
The unique device identifier (UDI) for each medical device or batch of medical devices must be recorded in the device history record (DHR).
The accuracy of labeling and packaging must be reviewed prior to the release or storage of the product. It should include the correct UDI or other device identification(s), the date of expiry, storage and handling instructions.
This is also part of the new requirements where all details related to servicing activities must be recorded, including the UDI or other device identification(s), the date of service, the service engineer, the nature of service, and any test or inspection data.
This should comply with the requirements of 21 CFR Part 830 Unique Device Identification and 21 CFR Part 821 Medical Device Tracking Requirements.
21 CFR Part 803 Medical Device Reporting requires that complaints be investigated and reported to the FDA, capturing information such as name and identification of the device, the date the complaint was received, the complainant details, the nature and details of the complaint, corrective action taken, and the reply given.
ComplianceQuest is a cloud-based Quality Management System that is aligned with ISO standards, enabling businesses to comply quickly and easily. The QMS includes features that can empower businesses to adapt to the new requirements of the QMSR on the go. Some of the key features that enable this include:
To know more about the ComplianceQuest EQMS, visit: www.compliancequest.com
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