Image courtesy of Eurofins Medical Device Testing
Compliance, Data Integrity, and a Robust Quality Management System
It may seem obvious, but the compliance, quality, and data integrity provided by your testing partner is critical to the overall success of the product. But how can a sponsor be sure that a laboratory will deliver quality data?
Start by conducting a quality audit of your prospective partner and look for a demonstrated record of success. Do they have any 483s or warning letters? Check the FDA Website for red flags. It’s important to do your due diligence before entering into a partnership.