Quality Management Solutions for Life Sciences Achieve closed-loop quality for CAPA, nonconformance, complaints, document control, and other quality processes.

Software Solutions for Medical Device Innovators

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

Manage End-to-End Quality Processes

PTC PLM products are built on the premise that product quality requires more than late-stage testing. Rather, it requires a whole team and lifecycle approach. With the world’s first Internet-based PLM solution, medical device makers can govern lifecycle processes and achieve compliance with ISO 9001 and related mandates.

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

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PTC Quality Solutions for Life Sciences Innovators

FDA And The Case For QualityPTC solutions maximize patient safety while aligning with best practices for ISO 13485, FDA TPLC, and 21 CFR Part 820 regulations.    

  • Get up-and-running quickly with out-of-the-box best practices for CAPA, complaint, and nonconformance management
  • Manage DHF (Design History File) and DMR (Device Master Record) as an integral part of your engineering lifecycle
  • Reduce the cost of managing quality throughout your product lifecycle
  • Reduce the potential impact of poor quality on revenues and reputation
  • Leverage lessons learned to continuously improve products and processes
  • Document structured, controlled, and repeatable quality processes
  • Accelerate new 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 creates, controls, manages and distributes key corporate Standard Operating Procedures (SOPs) and policies easily. 

  • CAPA enables identification, root cause analysis, preventive action determination, and close-out of quality issues across the product lifecycle.
  • Nonconformance Management captures and manages manufacturing issues, ensure clear visibility across the company and coordinate root cause analysis for faster resolution. 
  • Requirements and Validation enables teams to capture, manage and validate product family requirements as well as traceability across requirements, parts, test cases and test results. 
  • Customer Complaints Management ensures quality issues are linked to corrective and preventive action plans. Streamline eMDR (electronic Medical Device Reporting). 

Medical Devices Manufacturers Software Selection Guide

The challenges medical device companies encounter are expanding. The FDA’s “Case for Quality” calls for manufacturers to ensure the highest levels of device quality and safety throughout product design. As a result, teams need to consider comprehensive closed looped solutions.

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More for Medical Device Manufacturers

Medical Device Quality, Technology and IOT

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Improve Medical Device Quality Management With Windchill | PTC

Drive business results and continuous innovation by transforming your engineering practices and product designs.

2017 Axendia Report
Managing Medical Devices Across The Total Lifecycle. Read the report now!

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