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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
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
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The Pulse of ComplianceQuest: Our newsroom shares stories of innovation, progress, and change
Partners
Stronger Together: How our partnerships drive success and innovation
Upcoming Events
Today, MedTech companies are required to design and develop medical devices and products that comply with Good Design Practices keeping in mind the following aspects: usability, better quality, and patient safety. The industry as a whole is also facing a severe resource crunch, especially in the post-Covid world, requiring the companies to
This requires a concurrent product development strategy wherein quality and safety become important aspects to consider right from the design stage. In the case of a new medical device being developed, a minimally viable product (MVP) is designed with a scalable architecture for future updates and adding of features without delaying releases.
This requires an approach wherein the process of design controls; requirements documentation and traceability; and product risk management becomes a focus right at the start.
Product managers and engineering leaders we spoke to at ComplianceQuest say that “the only way to gain a competitive advantage in today’s landscape is to have an uncompromising approach towards quality and safety – right from the design and development stage.”
Digital transformation and industry 4.0 technologies have disrupted how businesses function across sectors. In the MedTech industry, there is now greater use of technologies like AI, advanced analytics, and IoT-enabled sensors to capture data.
While there’s rapid innovation on one side, there’s also increasing scrutiny and evolving regulatory requirements to tackle.
Some of the key emerging trends include –
Trend #1 – Changing User Preferences: Customer is always king. But technology has again put the user in the center, even for medical devices that originally needed the expertise to operate. Today, devices traditionally managed by physicians and/or surgeons are being operated by nurses and medical technicians. Therefore, the user interfaces are undergoing a sea change, becoming intuitive and simpler to operate. Some devices also need customization based on patient needs, which need to be factored in during the design and development process.
Trend #2 – Sensors and Embedded Devices: IoT is being leveraged to enable the real-time monitoring of patients remotely. Wearable devices monitor vital parameters and alert in case of any alarming signs.
Trend #3 – Telemedicine: Remote consultation with medical professionals can be a blessing for those living in remote locations and finding the commute taxing. Being able to consult a professional from the comfort of their home or hospital bed makes for greater efficiency without compromising on the quality of consultation. Covid further boosted this due to the lockdowns and the need for social distancing.
Trend #4 – Ensuring Security: Healthcare is a sensitive issue and needs highly secure devices. Since access to data in the wrong hands can lead to several problems including with the regulatory bodies, design must incorporate security as integral to development.
Trend #5 – Gene and Cell Therapy: This is gaining popularity to address rare or incurable diseases to improve outcomes but is highly challenging due to the highly personalized nature of the process and the challenge in designing, developing, and delivering them. They require several factors such as Chain of Custody and risks to be managed efficiently.
Trend #6 – Analytics & AI: The use of sensors and telemedicine is generating lots of data that can be useful in feedback and continuous improvement of the products. Therefore, a robust reporting and analytics capability is an essential part of device design and development. Additionally, we’re seeing AI models being deployed into MedTech products, to enable doctors and other healthcare professionals to use data better and garner insights.
Trend #7 – Predicting Trends: Along with feedback about the device’s performance, the manufacturers also need data to predict trends and be prepared with strategies to meet these trends. Access to big data – along with the device data – becomes important to know what tomorrow brings.
As regulations, user needs, and industry trends change, device manufacturers also need to be able to keep pace to remain relevant. Earlier, the design and development of a product took time. Today, the product development lifecycle has to be shortened without compromising on quality and performance. Product design, development, and security have to be closely aligned and integrated so that there are no delays or surprises. The process needs to include requirements traceability and enable identifying and managing risks.
ComplianceQuest Product Design and Development Solution empowers MedTech companies with features for Design Controls, Requirements Traceability and Risk Management.
To know more about CQ’s Product Design and Development Solution, visit: https://www.compliancequest.com/requirements-traceability/
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