Ever increasing government regulations, customer requirements and supply chain concerns require each manufacturer’s attention and resources.
PTC offers solutions to track and manage the compliance of your products, beginning early in the innovation process, and continuing throughout the product lifecycle. And it’s industry-proven; used by leading manufacturers across the enterprise for greater visibility into their product risks.
Meet the Compliance and Quality Activists
Meet the change agents who are taking a fresh look at improving quality across the medical product lifecycle.
Build compliance into the earliest phases of product development, identify and resolve compliance issues before they become costly problems.
Demonstrate product and supply chain compliance and due diligence for customers and government authorities.
Enable a systematic design-for-compliance process, explore the compliance status of design alternatives using what-if analyses.
Create exhaustive audit trails backed by real data – from simple certificates of compliance to full material disclosure.
Take more informed decisions, fewer late-cycle changes, and reduce downstream costs.
Stay up to date with changing compliance requirements and increase the accuracy of your reporting.
Close the loop between quality practices and product lifecycle
Medical device companies are shifting their focus from compliance to high quality, innovative products.
During the webcast, Axendia previews their research study findings. These findings highlight how Medical Device companies use technology to support a culture of innovation and quality.
Establish CAPA practices Meet CAPA standards, and demonstrate compliance with extensive failure reporting best practices, including ISO 9000, Six Sigma, APQP, CMMI and FDA 21 CFR Part 820. All failures must be documented, tracked and analyzed for root cause, and corrected or prevented in current and future products.
Windchill CAPA utilizes core Windchill features, such as change management, to ensure that different teams throughout the organization are coordinated and involved in correcting and preventing product errors.
Enterprise-wide system visibility — Enables failure intakes, recordings and traces and provides documentation of corrective/preventive actions taken.
Fully integrated — Supports Windchill modules to meet compliance requirements for change management, review and approval, document management, and training management.
Web-based accessibility — Enables easy access to critical quality information.
Standalone or integrated with other enterprise-wide systems provides flexibility.
Stay up to date with changing CAPA requirements and increase the accuracy of your reporting.
Make the Right Choice – Achieving the case for Quality
The medical device industry faces heavy regulations, and for good reason. With lives at stake, patient safety is of the highest importance.
Failure to adhere to FDA, EU, and other standards and regulations leads to embarrassing and costly product recalls. The case for quality and compliance is critical. Your profits, and indeed your company, are on the line.
Listen to Sri Tupil, Vice President of Software Quality Engineering and Product Management at Fresenius and Michelle Boucher, Vice President for Research at Tech-Clarity discuss current industry trends.
Improve future product designs and ensure a loyal customer base.
Recording customer complaints and tracking their resolution is also an essential step in remaining compliant with quality initiatives – including ISO 9000, APQP, and medical device standards like FDA CFR 21 Part 820. And for Medical devices, submitting eMDRs (Electronic Medical Device Reports) is critical to compliance.
Windchill Customer Experience Management delivers a highly structured, automated, and repeatable processes necessary to meet regulatory requirements for addressing external quality issues reported through customer complaints.
Customer complaint processes can include corrective and preventive actions, change and configuration management, document management, and BOM management.
Detailed, out-of-the-box workflows for follow-up actions, return product investigation, and regulatory safety reporting.
Ease-of-use and web-based access for rapid data entry and processing.
Uniform capture, codification, and processing of all customer feedback.
Powerful queries, graphs, scheduled reports, and alerts enable visibility into quality trends.
Quickly enter and access complaint records with Call Center functionality, history, and lookup.
Automated submission of eMDRs (electronic medical device records) to the FDA’s database in support of critical Medical Device regulations.
Manage Internal Nonconformance
Manage the intake, evaluation, resolution and tracking of product and process nonconformance. To support product quality, companies are increasingly embracing quality governance initiatives, including ISO 9000, APQP, Six Sigma and a wide variety of medical device standards like FDA CFR 21 Part 820.
Windchill Nonconformance supplies the highly structured, automated and repeatable processes necessary to meet regulatory requirements for internally addressing non-conforming products. Nonconformance processes can include corrective and preventive actions, change and configuration management, document management, and BOM (bill-of-materials) management.
Nonconformance metrics — Easily evaluates, assigns, monitors and reviews each nonconformance.
Built-in templates — Supports regulatory compliance across various industries.
Flexible workflows — Simply configures to match existing business processes.
Intuitive Web-based accessibility — Ensures rapid data entry and processing.
Extensive reporting — Easily and automatically generates audit trails, summary and management reports.
Life Data Analysis Predicts Part Failure
Weibull analysis, also called life data analysis, estimates a product's important life data characteristics — including reliability or probability of failure at a specific time, mean life and failure rate. To accurately predict performance over a product’s life, it's essential to gather and analyze life data from a variety of sources, including design and development, testing, field studies and customer returns.
Windchill Weibull predicts failure behavior using data from all phases of a product’s life. The software enables manufacturers to track reliability growth, analyze product degradation, plan product testing procedures, calculate optimal maintenance periods and perform warranty forecasting — in one powerful statistical package.
Effective for all types of products, including mechanical, chemical, electronic, material and human failures.
Supports degradation analysis to estimate failure times by tracking part decline.
Supports data-gathering methodologies, including inspection, interval, exact times and suspensions.
Performs warranty forecasting using sales and returns data.
Supports reliability growth methodologies to measure product improvement during the design phase.
Features intuitive interface tools, plus a comprehensive selection of plots and graphs.
Want to learn more?
Learn about the best practices for establishing a closed loop compliance and quality process