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Product Quality and 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.

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Product Quality and 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.

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Product Quality and 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.

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Solution Capabilities

Explore the key areas of this solution.

Requirements Management

Requirements Management

Capture and communicate requirements from every source with our integrated platform for medical device organizations. Quality and regulatory requirements are elevated, visible, and traceable at every phase in the device lifecycle.

Design Control

Design Control

Combine innovative design and engineering features without compromising quality or compliance. Our design control solutions for medical devices create seamless, faster design processes while balancing all elements of control.

Product Simulation

Product Simulation

Simulate products across multiple domains and locations. Our medical device simulation capabilities are specifically designed for managing processes to quickly derive and generate computer-aided engineering structures for the most complex devices.

DHF & DMR Management

DHF & DMR Management

Manage design history files and device master records with our DHF and DMR solutions for medical device manufacturers. Ensure quality, compliance, eliminate paper and mitigate risk.

Change Control

Change Control

Oversee progress, manage risk, resolve issues and ultimately effectively integrate change control processes utilizing accurate data and procedures by using our change control solutions for medical device companies.

Document Control

Document Control

Streamline medical device document production with accurate templates and consistent document structures. Manage product change configurations and revisions for design re-use and future device development.

Substance Compliance

Substance Compliance

Accurately rate and report medical device products for compliance mandates, including social regulations and conflict materials. Develop customized rules for your organization with personalized reporting capabilities.

Manufacturing Simulation & Validation

Manufacturing Simulation & Validation

Optimize your medical device manufacturing at the earliest stages, resulting in right-first-time planning. Improve time-to-volume-production times, achieve faster ramp-up, and deliver safe, high-quality products.

3D Variation Analysis

3D Variation Analysis

Improve product quality, cost, and speed with our 3D variation analysis tools for medical devices. Our processes can predict variation through a digital prototype, predicting problems at early stages in the lifecycle.

Manufacturing Execution Management

Manufacturing Execution Management

Enable a more connected, efficient value chain and ensure complete visibility between your production and engineering domains with our intelligent manufacturing solutions for medical devices.

Performance Data Analytics

Performance Data Analytics

Drive improved device performance back into design, engineering and manufacturing by combining and analyzing big data sources within a single integrated platform.

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Product Quality and Compliance Excellence

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.

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