Medical Equipment & Device Industry
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.