Know how IQ, OQ and PQ—the three essential elements of a Quality Assurance System—govern the medtech sector.
The 1000-dollar genome presents a big opportunity in medicine.
The assay provides results in less than 3 hours.
The deal creates the largest global sterilization and lab services operation.
Following a safety alert, the agency issued an update about possible counterfeit raw materials in urogynecologic mesh implants.
Part three of the design verification series discusses in detail the steps that should be taken during testing.
Prior to design verification of packaged products, consider the following process-related elements.
This three-part series explains how an all-encompassing testing approach will improve product reliability and secure your bottom line.
Well-written and usable instructions are critical for all users.
The biological safety of a device is established for both short-term (acute) and longtime (chronic) safety risks to patients and device users. Medical device manufacturers must investigate their devices thoroughly to meet these expectations to receive approval to market their devices.