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