Manage end-to-end quality processes, and gain holistic insight into product quality.

“Manage end-to-end validation and verification processes, and gain holistic insight into product quality.”

— McKinsey, The Business Case for Medical Device Quality

For medical device manufacturers, ensuring patient safety is both a moral and financial imperative. Quality practices are mandatory. More importantly, they are integral to the successful delivery of medical innovation.

Silo’d Systems Leads to Missed Opportunity

Many medical device manufacturers manage regulatory workflows using paper-based systems or disconnected, single-purpose software solutions. For these organizations, regulatory record-keeping amounts to an overhead activity that depletes time, money and resources.

Our Quality Heritage

Quality Solutions For The Medical Device Industry

PTC PLM products were built on the premise that product quality requires more than late-stage testing. Rather, it requires a whole team, whole lifecycle approach. We invented the world’s first Internet-based PLM solution – Windchill – partly in order to help customers govern lifecycle processes and achieve ISO 9001 certification.

From these quality-centric roots, PTC has extended its core Windchill product lilfecycle management capabilities into a suite of offerings designed to help medical device manufacturers streamline, simplify and gain greater value from their quality investments.

Stryker Endoscopy improves safety and streamlines regulatory reporting.

Best Practices Delivered

Best Practices Delivered

PTC’s Medical Device quality solutions deliver pre-configured, out-of-the-box best practices designed for life sciences companies. The solutions maximize patient safety and efficacy while following best practices for regulated life sciences environments, and are harmonized for ISO 13485, FDA TPLC and 21 CFR Part 820 regulations.

  • Get up-and-running quickly with out-of-the-box best practice configurations
  • Reduce the cost of managing quality throughout your product lifecycle
  • Reduce the potential impact of poor quality on revenues and reputation
  • Make quality a shared lifecycle responsibility, not an afterthought
  • Leverage lessons learned to continuously improve products and processes
  • Document structured, controlled and repeatable quality processes
  • Accelerate product introductions by qualifying for FDA Case for Quality trusted vendor status

PTC quality management capabilities for medical device manufacturers includes:

  • Design Control ensures that product development teams follow a common design control and product realization process.
  • Document Control enables easy creation, control, management and distribution of key corporate Standard Operating Procedures (SOPs) and policies. Tracking of training activities is also available.
  • Corrective and Preventive Action provides for closed-loop identification, root cause analysis, corrective / preventive action determination, and close-out of quality issues across the product lifecycle.
  • Customer Complaint Management manages customer complaints to ensure that quality issues are linked to corrective and preventive action plans, and streamlines eMDR (electronic Medical Device Reporting).
  • Internal and External Audit management provides a quality governance process to ensure that key corporate processes, requirements and directives are being followed by both internal and third parties.
  • Nonconformance Management captures and manages manufacturing issues, ensuring clear visibility across the company and coordinating root cause analysis for faster resolution.
  • Requirements and Validation enables teams to capture, manage and validate product and product family requirements, and enables traceability across requirements, parts, test cases and test results.
  • Unique Device Identification (UDI) collects and controls UDI data, automates UDI approval, data verification, and electronic submission workflows, and streamlines change control and version management.

Learning Resources for Medical Device Manufacturers

2017 Medical Devices Manufacturing Software Selection Guide from Tech-Clarity

Download your free copy today!

2017 Axendia Analyst Report: Managing Medical Devices Across the Total Lifecycle

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Explore PTC Solutions for Medical Device Manufacturers

Read the eBook

The Windchill Quality Solution

Watch the Demos

Novo Nordisk Discuss Quality with Tech-Clarity

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Tech-Clarity Discusses Quality with David Wolf PTC

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Comply with 21 CFR Part 11 and Annex 11 Using Windchill

Read the Report