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
The COVID-19 pandemic was an eye-opener. Despite all the advancements in science and technology, the world came to a standstill due to this virulent virus that spread rapidly, causing death and disease and compelling lockdowns to curtail its efforts. It also revealed the need to be ever-prepared to face such unforeseen calamities and ensure the safety of our public spaces, including the workplace.
The FDA, as part of its commitment to keeping employees safe through stringent health and safety measures, is building a forward-looking Center for Devices and Radiological Health (CDRH) that leverages technological innovations to manage and combat unforeseen health challenges at the national level, all while remaining dedicated to engaging with and serving the American public.
The three Strategic Priorities for 2022-2025 represent a seamless progression building upon the accomplishments of the FDA’s previous Strategic Priorities from 2018-2020, with further continuity into 2021. These priorities are aimed at:
CDRH has outlined its prioritized guidance documents to be published in FY2023. These guidance topics encompass both final and draft versions.
A-List:
Final Guidance Topics:
Draft Guidance Topics:
B-List:
These guidance documents provide important information for manufacturers and stakeholders in the medical device industry to ensure the safety and effectiveness of medical devices and streamline the regulatory processes.
The Digital Transformation Initiative of CDRH aims to enhance the user experience for both internal and external FDA customers. This initiative focuses on improving data acceptance, storage, analysis, and distribution capabilities while modernizing and digitizing CDRH's programs and operations. Currently, CDRH relies on over 30 outdated and complex data systems for premarket review, leading to inefficiencies and high costs for upgrades and maintenance. The organization invested in an integrated knowledge management system with secure cloud-based data storage to address these challenges, facilitating better data delivery to staff and external stakeholders. This initiative represents a long-term capital improvement effort to drive positive changes in CDRH's digital infrastructure.
Technological advancements and the FDA's push for improved post-market reporting and safety monitoring will impact businesses in the medical device industry. To meet the changing scenario, companies must embrace digital transformation, prioritize safety, stay informed about regulations, foster innovation, and collaborate with stakeholders. Adapting to these changes will be vital for their success and public health improvement and enable compliance with the Digital Transformation Initiative requirement by providing advanced reporting and analytics, streamlined complaint management, quality control solutions, EHR integration, cybersecurity, and data privacy measures. These offerings support better post-market reporting, monitoring, and overall patient safety while facilitating the adoption of innovative and safer medical products.
Recently, ComplianceQuest presented a webinar on “Understanding the FDA’s Strategic Priorities for CDRH for 2023 and Beyond”. This webinar talks about CDRH proposed guidelines for the fiscal year 2023, CDRH Office of Digital Transformation Plan and the difference between draft guidance and final guidance.
Learn about all features of our Product, Quality, Safety, and Supplier suites. Please fill the form below to access our comprehensive Demo Video.
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On January 31, 2024, the US Food and Drug Administration announced an amendment to 21…
Medical devices that are to be placed in the United States market must meet the…