Ir para o Conteúdo

Product Quality & Compliance Excellence

Product Quality & Compliance Excellence

Success in the medical device industry requires not just meeting, but exceeding quality and regulatory standards. Our Product Quality and Compliance Excellence solutions provide an integrated, seamless production program that spans the entire device lifecycle. 

Our proven methodologies ensure insight and traceability at every stage in the process, reflecting fewer adverse events and product recalls, significant cost reductions, and safer, more innovative products.

Success in the medical device industry requires not just meeting, but exceeding quality and regulatory standards. Our Product Quality and Compliance Excellence solutions provide an integrated, seamless production program that spans the entire device lifecycle. 

Our proven methodologies ensure insight and traceability at every stage in the process, reflecting fewer adverse events and product recalls, significant cost reductions, and safer, more innovative products.

Learn More About Product Quality & Compliance Excellence

Request a Product Quality and Compliance Demo from our Medical Experts

Product Quality & Compliance Excellence

Achieve Product Quality and Compliance Excellence with our solutions for quality control and regulatory compliance in the medical device industry. Operate with the most efficient, cost-effective processes possible thanks to our advanced digital lifecycle management technology.

Learn More

Medical device companies are challenged to maintain controls for quality assurance and regulatory compliance across every phase of the device lifecycle. To do so, systemic approaches are needed to provide transparency, traceability and early-stage error detection. This is especially true as products continue to become more personalized and complex, and the marketplace continues to become more global and competitive. Our Product Quality and Compliance Excellence solutions provide technology-enabled processes to ensure proactive quality assurance, and are combined with strategies to increase efficiency, minimize risk and enhance product innovation.

With our digitalized, integrated platforms, globally diverse companies can identify and resolve quality issues at the earliest possible stage. By embedding and utilizing analytical data throughout the product lifecycle, med-tech organizations can support higher production rates, reduced cost of goods, and more efficient regulatory-mandated control processes. Also, the likelihood of adverse events or product recalls can be dramatically reduced, if not eliminated entirely. The result is the achievement of true product excellence, which in the end means realizing innovative and safer devices, improved patient outcomes, and significant increases in the bottom line.

Solution Capabilities

Dimensional Quality

Ensure product quality in production by understanding the impact of dimensional variation before design release.

Document Control

Effective document control is the core of any compliance program. Document control provides a flexible framework for the creation, modification, approval, release and archive of all compliance and quality documentation. Web-based document control provides access to all relevant documentation at any time and from anywhere. It ensures full documentation of processes with change history and audit trail and meets requirements in accordance with FDA 21 CFR Part 11. 

Human Factors & Ergonomics

Design products with improved ergonomics in mind and assess human factors for operations to help plan safer workplaces.

Integrated Quality Management

Meet all technical and performance requirements at cost and on schedule. Our quality management solutions for medical devices give you the ability to improve product quality and reduce costs across the entire product lifecycle.

IoT & Lifecycle Analytics

Leverage the Internet of Things to achieve agility, speed, and compliance at your medical device or pharmaceutical organization. Our solutions are equipping med-tech organizations with the transparency and advanced analytic tools required to gain a competitive edge using big data.

Manufacturing Execution Management

Our manufacturing execution management solutions are a highly sophisticated, scalable, digital suite that delivers multiple capabilities and allows your med-tech organization to combine production efficiency with quality and visibility, as well as production optimization.

Materials Management

Our environmental compliance management solutions for the medical device industry serve as an effective and rapid response to the global quest to protect our planet and its inhabitants. Our systems support sustainability at every phase in the product lifecycle which enable med-tech companies to achieve success on many levels.

Requirements Management

Manage product requirements with our systematic and repeatable solution for building-in the voice of the customer, enabling medical device companies to easily capture, securely manage, accurately verify, and reliably maintain requirements information across the entire device lifecycle.

Simulation & Testing for Medical Devices

Simulation is playing an increasingly significant role in the development of medical devices, saving development costs by optimizing device performance and reliability, reducing benchtop tests and clinical trials, and helping to speed the regulatory approval process. Our deep portfolio of simulation and testing solutions allows medical device developers to generate digital evidence of device performance across a range of engineering disciplines, throughout the product life cycle.

Interested in [[global-preference-center-interest-placeholder]]?

Subscribe to [[global-preference-center-interest-placeholder]] updates

Oops

We're very sorry, but we weren't able to capture your submission. Please try again.

Thanks for signing up! First time subscribing? Be sure to check your email to confirm your subscription.