Quality Solutions for Medical Device Manufacturers 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.

Software Solutions for Medical Device Innovators

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 quality investments.

Learn More About The Windchill Quality Management
Solution

PTC’s Medical Device Quality Solutions

FDA And The Case For QualityOur solutions maximize patient safety while following best practices. They are also 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 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.

Get Your Copy Now

More for Medical Device Manufacturers

Manage your medical device from design to service

Talk To Us About Medical Devices

Take this opportunity to speak with our PTC Medical Device Solutions experts.

Contact us now !

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!

Awareness Unlocks Potential
Explore PTC Solutions for Medical Device Manufacturers. Read the eBook now!

What our customers say
Find out how customers like Stryker and Novo Nordisk deliver dependable products.

How to buy
Find out more about our subscription offer for Medical Device Manufacturers.

 

2017 MEDICAL DEVICES MANUFACTURING SOFTWARE SELECTION GUIDE

Available Now!