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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
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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.
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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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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.
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Over the last few years, we’ve witnessed rapid growth and major innovations in the medical device landscape. According to market research conducted by Fortune Business Insights, the overall market for medical devices is expected to touch USD $657.98 Billion by 2028. We’re seeing significant contributions not only from large enterprises like Medtronic, Abbott, Siemens Healthineers, and GE Healthcare, but also from a wide range of VC-backed startups.
We’re witnessing potentially game-changing partnerships; for instance – GE Healthcare partnered with Nvidia to bring an extremely advanced AI platform to highly complex medical devices, all with the goal of improving patient safety. Apple Watch 4 is an FDA Class 2 Medical Device that can detect heart rate, falls, or trips, among other parameters.
Overall, there is serious innovation happening through a combination of hardware and software breakthroughs – even as regulators are keeping pace to ensure patient health and safety above everything else.
Medical devices form an essential part of the treatment procedure for almost all health conditions, playing a significant role in various aspects right from diagnosis to therapy. It is essential to ensure their effectiveness in meeting the intended objective and also be safe to handle.
Medical devices may contain many electronic parts and/or components to perform chemical analysis and they often use electricity. Most of them are handled by diagnostic staff, nurses, attenders, and other humans during the treatment procedure. The patients definitely come into close contact with the devices, some of which may even be inserted into the body or placed on the surface of the patients.
Keeping all this in mind, it is critical that medical device company does whatever it takes to ensure the safety of the device. The safety process used by the company must take into account all the use-cases and be optimized for various people who come in contact with or close to the device – the person operating the device, patients, doctors, para-medical staff, lab technicians, etc.
Therefore, the safety solution for your medical device must come with integrated risk management capabilities.
To ensure that only safe devices are used, the Food and Drug Administration and other similar regulatory bodies delineate regulations that must be complied with at every stage of the manufacturing process. This increases the safety effectiveness quotient of the device.
Medical devices can be placed in the market only after being vetted by the regulator. Any non-compliance or serious undetected health hazard can cause the device to be recalled. This will impact the business performance in terms of the costs involved and brand reputation. The costs can come in many forms:
The lifecycle of a medical device manufacturing process is long and needs significant investment for research, design, manufacturing, testing, and so on. Therefore, an event like a product recall lays waste to all the effort that has gone into its production and other stages before that. If the device cannot be reworked, it may have to be scrapped and the wastage adds to the cost. The process must begin from scratch, which involves time and investment.
It is in the best interest of the patient, the handlers, and the manufacturers that the device is manufactured right the first time. However, even with the best of intentions, mistakes happen and the device may not be compliant and safe.
Some of the factors to keep in mind in the manufacturing of medical devices to ensure their health and safety include:
Data-Backed Design: Human beings are unpredictable and each user of a device is different from the next. Since devices need human interaction and how that interaction happens can impact the safety quotient of the device, research into comparable products, their designs, risks, and other such data are important right at the design stage.
This, along with other factors such as the best material to use, other design aspects, the right set of suppliers, and the ideal manufacturing partner, all require data to make an informed decision that will improve the device’s safety. Data can be obtained from regulatory agencies and independent bodies. This can be supplemented with research by the organization to fine-tune the product and make it unique.
Testing Before Release: Once the product is ready, it must be tested under various conditions to ensure its stability and safety. In today’s globalized world, the device may be used anywhere from Alaska to Australia, in all kinds of weather conditions, with varying levels of electrical and network connectivity, etc. The device must have a consistent performance under all these varying conditions and, more importantly, be safe.
Post-Market Surveillance: The journey does not end after releasing the medical device into the market. Customer feedback and performance tracking are essential to ensure that the device is indeed achieving its purpose in a healthy and safe manner. This is important to fine-tune and continuously improve the product. Any negative feedback should be handled appropriately and action must be taken immediately to improve the design and performance.
Documentation and Risk Management: Documentation and follow-up are very essential, especially in large markets such as the U.S., Canada, and Europe, to demonstrate compliance with ISO 14971. Documentation and implementation of systematic risk management processes throughout the product lifecycle are essential for this.
For device manufacturers, safety management can become a challenge as they try to balance the cost and time of innovation and the product lifecycle. Safety may often seem like a hindrance to faster growth and compliance may become lip service, just enough to keep the regulators happy. Often this is because the safety management systems are manual or legacy systems – and access to data to make informed decisions, and implement root cause analysis, or CAPA may become difficult.
A cloud-based safety solution such as ComplianceQuest provides a holistic view of organization-wide data by seamlessly integrating with systems such as ERP, CRM, and so on. It is a flexible, modular, next-gen solution that helps safety leaders and production teams to identify risks, put controls in place, and reduce or eliminate the risks.
As the data is documented, it helps with reporting and also labeling so that precautions can be elucidated to prevent mishaps. This documentation also helps with correctly classifying the risk category the product belongs to right from the beginning. Any feedback is ingested and processed, providing the safety leaders with the opportunity to incorporate the feedback to improve the safety and usability of the device.
Additionally, CQ EHS integrates with our EQMS and Design Controls Solutions, which may be an ideal solution for your organization.
To know more about how the CQ Safety Solution can help your company’s health and safety team, visit: https://www.compliancequest.com/industry/medical-devices/
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