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ProductCenter PLM Success

Medical Equipment & Device Market

Medical equipment and device manufacturers have the compounded task of adhering to Food and Drug Administration (FDA) regulations, strict but important to product quality and ultimately, patient safety. The FDA requires accurate, meticulously controlled drawings, documents, and procedures for managing electronic data from pre-market approval to final shipment of products.

Meeting FDA Rule 21 CFR Part 11, ProductCenter Product Lifecycle Management (PLM) makes sure that missing or inaccurate data is never a problem and that complete, up-to-date documents can be presented to the FDA at a moment’s notice. It also ensures that production is driven by current information, eliminating non-compliance that can have devastating consequences for a business in this industry.


News
SofTech Collaborative PLM Implementation Expanded at Medrad
ProductCenter PLM Targeted to Provide Additional Efficiency Gains with ProductCenter PLM AutoCAD Integrator and ProductCenter PLM GenView


Customer Success
Medrad Speeds Time to Market and Meets Regulatory Needs
ProductCenter PLM Pure Success at Millipore
ProdyctCenter PLM Solution Facilitates Global Design and Manufacturing for Leading Industrial Purifi cation Filter Manufacturer

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"The FDA was impressed with our demonstration of how it [ProductCenter PLM] would enable us to meet its regulations. When it saw, the FDA said our methods would exceed its requirements."



Customers