Comply with 21 CFR Part 11 and Annex 11 Using Windchill

Software Solutions for Medical Device Innovators


PTC’s Windchill® Product Lifecycle Management (PLM) System Facilitates Part 11 / Annex 11 Compliance

In the complex and heavily regulated life science industry, companies must ensure compliance with numerous regulations and standards. For electronic records of product-related data, they must comply with U.S. FDA 21 CFR Part 11 and Europe´s Annex 11 regulations.

Windchill, PTC’s Product Lifecycle Management (PLM) solution helps meet these compliance regulations.

Learn how Windchill helps regulated customers care for their records and meet both sets of requirements. 

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

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