Original Equipment Manufacturers (OEM) of medical devices must perform and pass FDA approved medical device process validation and verification before any product can be introduced on the market. In the medical device industry, process validation and verification is a term that indicates that a product, service or other outcome has been subjected to such scrutiny that the result of the process can be practically guaranteed. This is significantly important not only to satisfy FDA requirements for public health and safety but to ensure business success. Processing deficiencies may only be revealed through process validation and verification.
What is the validation process?
Validation of a process involves demonstrating that a product will consistently produce and comply with predetermined requirements as defined in its design and development. It is defined by the FDA as “confirmation of a product by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled.” Process validation is designed to establish by “objective evidence that a process consistently produces a result or product meeting its predetermined specifications.” FDA regulations state that verification is defined as “confirmation by examination and provision of objective evidence that specified requirements have been fulfilled.”
These are necessary steps to ensure that all medical devices meet regulatory standards for the health and well-being of the public. No doubt that the wide range of challenges that OEM’s of medical devices encounter in manufacturing specific products is immense. Medical devices are manufactured by OEM’s whose size, structure, management methods, production capacity, and assembly lines can vary substantially. Production and assembly, i.e., the number of manufacturing steps per unit (e.g. adhesives or soldering steps) will considerably influence how process validation and verification will be applied.
What products need to be verified?
Technologies and applications must vary to meet the challenges above. Medical devices range from small hand tools to complex computer-controlled surgical equipment; from implantable pins, rods, screws, and plates to artificial limbs and organs. Something as minor as blood-glucose testing strips to major diagnostic imaging systems such as X-ray and ultrasound, computed tomography (CT), magnetic resonance imaging (MRI), and nuclear or positron emission tomography (PET)—even laboratory test equipment—must go through the regulatory process.
The completion of process validation is a regulatory requirement that a manufacturer must adhere to. It is best to start the validation and verification process as early as possible and choose the right validation expert to guide your product through the required steps. Properly controlled design and development activities can reduce the length of time to market for new products.
Are there compliance protocols in place?
In general, to meet compliance and award approval, manufacturers should follow three protocols with the overall objective to formulate a plan to: obtain data, record data, and interpret data. The process begins with the installation qualification (IQ) protocol. Whereby, an initial qualification of the equipment used and provision of necessary services are met. The second step is the operational qualification (OQ) protocol to demonstrate that the process will produce acceptable results, test limits and establish process parameters. The third phase is the performance qualification (PQ) protocol. This step should be designed to establish long-term process stability.
In sum, OEM’s are legally obligated to meet the requirements for process validation and verification as established by FDA regulations. Understanding how to perform process validation is therefore vital to a company’s success. Compliance in performing process validation will help ensure a predictable and predetermined outcome, reduce the time it takes to get a medical device to the market, help reduce costs, and successfully complete process validation and verification of your product to receive FDA approval.