SFDC/DHR Interface Systems Add Parametric Data to Support Medical Manufacturers

In this era of ever more stringent FDA oversight and regulations, the responsibility for vigilance falls on medical manufacturers and their manufacturing partners or customers. Those companies that support a “best practices” medical manufacturing environment often rely on a shop floor data collection (SFDC) system that embeds attributive data in each unit’s device history record (DHR). More recent advances allow for parametric, or performance, data to be captured as well, so that not only can the medical device’s progress through the manufacturing process be monitored, the device’s quality of performance at each stage can also be assessed. Access to this data facilitates timely decision- making, ensuring the highest quality medical product, and saving money due to reduced downtime, scrap and/or repair work.