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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.
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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
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Humans: The Real Superheroes of Artificial Intelligence (AI) in Quality Management
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ComplianceQuest Medical Devices QMS Success Stories eBook
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Aphria (now Tilray) CIO talks about their implementation of ComplianceQuest, Rootstock and Salesforce
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The Ultimate Guide to ISO/IEC 17025:2017 Compliance
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Safety Technology Trends to Watch in 2023 (Infographic)
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Data-driven Safety – Strategic Resources for Monitoring of Key Performance Indicators
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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.
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By Feb 28, 2019, medical device manufacturing companies should have completed their ISO 13485 transition to 2016 to maintain their certification. The transition brings with it several challenges requiring changes in processes and documents, introducing new ones being and ensuring not to lose the momentum that could risk current certification.
The implementation of the 2016 recommendations is expected to improve quality management throughout the medical device lifecycle, right from design, development, manufacture, test, distribution, installation to servicing of the medical device products. One of the important changes in the revision is that the new ISO 13485:2016 uses a risk management approach in all processes of the Quality Management System and will impact in the following ways:
ISO 13485 standard provides a sound basis for medical device manufacturers to meet medical device directives, regulations and responsibilities while demonstrating their commitment to safe and quality medical device products. It adapts the ISO 9001 process model of Plan, Do, Check, Act (PDCA) designed for regulatory compliance and is more prescriptive requiring a demanding quality management system and documentation. Its focus on continuous improvement will help device manufacturers increase efficiency, become cost-effective, improve supply chain management and quality.
Implementing this will facilitate greater access to markets worldwide as it is an internationally accepted standard. In the US, ISO 13485:2016 is only a voluntary standard right now though the FDA is considering replacing QSR 820 with it, making mandatory. In the EU, ISO 13485:2016 is a regulation for certification and EN ISO 135485:2016 has been harmonized to the new EU medical device directives, requiring conformity by March 31, 2019. In countries such as Canada also, it is considered as a regulation and medical device companies aiming to join the MDSAP program (single audit program), ISO 13485 is required. Japan and Australia too have regulatory requirements aligned with this standard. By complying with the standards, the device manufacturers will be able to compete in any market without having to manage varying regulatory requirements.
While the benefits of embracing the new standards may seem evident, the process can seem daunting. It requires, first, a culture of quality, a team of qualified quality experts, the willingness to take ownership of the transition and management buy-in. Even when external consultants are brought in, sustaining the efforts is possible only when the management and the employees support the effort and adopt best practices.
Some of the key challenges that an organization may face depending on its size include:
Outlining the goal and setting milestones will help motivate teams better as they start seeing results and thereby ensure their involvement for better success.
The second challenge, at this stage, is the timeline. There are only about 10 weeks left for a process that can take around 10 months from the time of registering to GAP analysis, , review, and two-stage audit.
Third is the process itself that needs great attention. Manufacturers must:
Modern Cloud Enterprise Quality Management System (EQMS) from Tampa, Florida-based ComplianceQuest supports the revised ISO requirements and can help automate the quality management requirements while maintaining full traceability.
Natively built and run on Salesforce, Modern Cloud EQMS offers a powerful, fully integrated platform for internal and supplier audits, change control, complaints, CAPAs, document control, equipment calibration, nonconformances and deviations, inspections, supplier quality, employee training and more.
Some of the features best suited for the transition regardless of the size of the organization include:
In addition, the ComplianceQuest team has several decades of experience in quality management and compliance. Its solution is reliable, versatile and scalable for all sizes of companies with built-in best practices and seamless processes that are integrated with Salesforce AppExchange partners.
Even if you have not yet started on your compliance process, it is never too late. Contact us and find out how we can help you with transition or implement ISO for the first time.
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