MEDICAL DEVICE VALIDATION DOCUMENTATION.

Validation of medical devices is mandated within the; FDA 21 CFR part 820.  These form part of the Quality System Regulations established by the U.S. Food and Drug Administration (FDA) to direct Medical Device manufacturers and ensure that their products consistently meet applicable requirements and specifications. The quality systems for FDA-regulated products (food, drugs, biologics and devices) are known as current good manufacturing practices (CGMPs).  Current good manufacturing practice requirements are set forth in this regulation, and are consistent with the requirements for quality systems contained in applicable international standards, like ISO 9001 and ISO 13485.  Quality System Regulations for medical device manufacturers do not regulate how a manufacturer must produce its product. Rather, the regulation defines the framework and elements that must be present in a quality system.

The regulators today expect medical device validation to perform to a high level. At the same time, the medical device business has become highly regulated. For medical device validation to perform in this environment, the production testing of medical device must have both compliant procedures and an excellent technical strategy.

The simple view that each medical device validation has a set of functional specifications and that each device produced must be tested to those specifications is both ineffective and inefficient. An exhaustive test for the complete specifications of an implantable cardioverter defibrillator (ICD), for example, would take significant energy from the device's battery and reduce its useful life. Exhaustive testing to functional specifications is best left to the design validation tests that are a required part of device certification.

A realistic and effective medical device validation test strategy requires several sets of test requirements based on component and manufacturing process specifications as well as critical functional specifications of the device. Test requirements describe and delineate setup conditions, stimuli and expected response parameters for individual experiments that constitute test steps. Test requirements are based on an understanding or model of real physical phenomenon. The model is never perfect, so measuring test coverage according to the test requirements is never perfect. Even a test that covers 100% of the requirements does not deliver a perfect product.

A set of medical device validation test requirements is needed because testing occurs repeatedly at different stages of manufacture, from component acceptance to final assembly. Each stage has a different set of specifications as well as different physical constraints on the test process.