Join ConQuest 2025 | ComplianceQuest User Conference | April 8–10, Clearwater Beach, FL
Discover your potential savings with our ROI Calculator
Middle Office Platform
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
Course Offerings
Recent CQ Guides
Featured CQ Guide
Datasheets
Brochures
Demo Center
Podcasts
Podcast
Aphria (now Tilray) CIO talks about their implementation of ComplianceQuest, Rootstock and Salesforce
Videos
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
Safety 2025 Conference & Expo
22 Jul, 2025
Orlando, FL
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 quality, safety and efficiency 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
Partners
Stronger Together: How our partnerships drive success and innovation
Upcoming Events
As the FDA is gearing up to harmonize QSR requirements with that of ISO 13485, the process of compliance will become more efficient for medical device companies. But, the key is to be prepared and take advantage of QMSR by using the right set of automation and digital transformation tools.
Medical Device Design & Development
The design and development of medical devices is a resource- and time-intensive process given the sensitive nature of the products. It's a journey of experimentation, research, and trial-and-error, combined with deep engineering and product management expertise.
Adding to the complexity are the varying regulatory requirements (of several regulatory bodies) in different parts of the world. To simplify this process and to unify the regulatory approach, international regulatory bodies have tried to minimize the differences and harmonize the needs.
QMSR Regulations
As part of this harmonization process, the US-based Food and Drug Administration (FDA) released a proposed rule for a new Quality Management System Regulation (QMSR) on February 23, 2022. The idea was mooted in 2018 itself but received a setback due to the COVID-19 pandemic which diverted the attention to introducing protocols to contain the spread of the disease. Now that the threat has been reduced, FDA is back to speeding the harmonization process.
With the proposed QMSR, the current good manufacturing practice (cGMP) requirements of the FDA’s Quality System Regulation (QSR) will be aligned closely with ISO 13485:2016, the internationally accepted standard for medical device quality management systems. The process will begin in March this year and is expected to be ready for implementation in a year’s time.
FDA’s QSR and ISO 13485 were first published around the same time in 1996. But, while ISO 13485 has been revised five times till now, the QSR has remained more or less the same. The alignment with ISO 13485 is expected to make FDA regulations on par with the internationally accepted regulatory expectations for QMS for devices but will continue to be under the FDA jurisdiction.
Benefits of ISO 13485
The ISO 13485 standard enables medical device manufacturers to incorporate best practices for manufacturing by establishing a set of interrelated requirements to create a Quality Management System. Implementing ISO 13485 can help medical device manufacturers maintain medical-grade quality, improve customer satisfaction, and achieve continual improvement.
By getting certified for this regulation, entry into international markets and customer acquisition will become easier. This standard is also recognized by the EU, thereby reducing the burden on US manufacturers to comply with the EU MDR QMS requirements.
ISO 13485 implementation will help manufacturers produce high-quality and safe products. They will gain insights into potential risks during the product development process, enabling them to proactively address and correct them. It will also improve inspection and traceability measures for all medical devices.
This standard also emphasizes the importance of setting up specialized processes for sterile medical devices and strict adherence to cleanliness requirements.
Harmonizing QSR with ISO 13845
In the current revision of 21 CFR Part 820, only the gaps are being addressed and the 2016 revision of ISO 13485 will be the point of reference. By aligning Part 820 with ISO 13485:2016, FDA will also be removing any redundancy or inefficiencies that act as roadblocks for medical device companies in complying with both QSR and ISO 13485. The harmonization will simplify compliance and reduce the burden while ensuring patients with better access to necessary devices.
Regulatory harmonization represents a process where regulatory authorities align technical requirements for the development and marketing of pharmaceutical products.
Harmonization will enable medical device companies to save anywhere between $439 million and $533 million due to the reduced compliance burden. It will also reduce the burden of compliance in terms of time and resources.
QMSR Vs QSR
According to the FDA, Part 820 and ISO 13485 are already similar in many ways and the changes are not expected to impact the basic QMS requirements for medical device companies. For example, ISO 13485 requires device companies to maintain a medical device file (MDF), which is the same as Part 820’s Device Master Record, which is going to be replaced with MDF.
Where ISO 13485 terms and definitions are inconsistent with the Federal Food Drug & Cosmetic Act and its implementation, the FDA definitions will supersede. For greater clarity, Section 5, Part B of the proposed rule explains FDA’s stance on harmonization.
Some of the new sections proposed in Part 820 include,
Some of the other key aspects to note include:
FDA’s QSR uses a risk-based approach to quality, but ISO 13485:2016 establishes the requirements more explicitly. Therefore, QMSR will draw heavily from ISO 13485 to stress risk management in design controls.
Please confirm your details
By submitting this form you agree that we can store and process your personal data as per our Privacy Statement. We will never sell your personal information to any third party.
Enter Captcha