Why Do Medical Devices Need to Go Through Validation?

The Contract Development and Manufacturing Market is expected to grow to $100 Billion by 2025, an 11.4% CAGR. This growth is partially fueled by the increasing burden of regulations including harmonized verification and validation standards between the FDA and ISO 13485.

What is medical device validation?

Medical device validation refers to the process of confirming a medical item, program, or software works in the way in which it was intended. Validation is essential to ensure each device is safe for use and will work correctly for all patients with no room for error or harm.

The FDA defines validation as establishing evidence that a process produces results while meeting the required specifications. 

What is involved in design and process validation?

Design validation focuses on the device and aims to create evidence that it meets all user needs and intended uses. In contrast, process validation uses a quality management system to look into the essential processes involved in the device's manufacture. This method of validation includes checking, testing, and recording the outcomes.

Why is validation important for medical devices?

It Guarantees Safety

The safety and performance of medical devices are validated in conditions and environments that would most benefit the patients. People's lives and health rely on functional devices, and there should be no room for error. Medical devices often have many parts, and it is essential to make sure every aspect works seamlessly to prevent technical errors that could compromise patients' well-being. Besides, during installation, the assembly needs to be validated to guarantee each piece is of the same quality and will consistently deliver a precise performance in its intended manner.

It Ensures Effectiveness

Medical devices are commonly used to diagnose, monitor, treat, or alleviate patients' medical conditions. Validating medical technologies before they are released to the market guarantees effectiveness in patient and disease management. When justifying a medical device's functionality, the validation process must demonstrate that it is technically superior to the gold standard, cost-effective, and efficient. Any device or technology must also be proven to be safe to produce consistent results. A robust validation procedure, therefore, guarantees the device will not fail in clinical practice.

Compliance is a Must

The FDA requirements and ISO 13485 guidelines advise medical device makers to verify that their products meet documented design specifications. Before introducing new medical devices to the market, manufacturers must validate that the manufacturing process has proper controls to guarantee the production of devices that meet specific user needs and safety, regulatory, and technical requirements.

However, verifying product quality means you test every device you produce, which is impractical in many cases. This is where process validation comes in to fulfill a crucial quality assurance requirement. The validation process subjects the device to intense scrutiny to determine whether the product's output process consistently meets established production quality specifications or not.

Watch our video series about biomedical innovation.

Which medical device production needs validation?

Ideally, the FDA guideline requires manufacturers to validate any new processes being implemented, techniques that have been modified or expanded, and the existing processes that need to be qualified regularly. The following are a few typical examples of processes that need validation:

• Sterilization and sterile packaging sealing
• Automated processes such as a rotary press
• Liquid mix and fill processes
• Seal strength of bags

When do I begin the validation process?

Typically, the validation process starts when you have a functional design and an ideal manufacturer who can competently complete the validation process. At this point, you will have to start the validation paperwork in the form of IQ, OQ, PQ. It is essential to note the design will influence validation, and you should consider the validation process from the earliest stage.

Conclusion

Validation uses objective evidence that proves the process is capable of consistently producing products that meet predefined requirements, including functional specs, regulatory requirements, and user needs. Validation is critical when the results of a process cannot be fully verified by inspection and testing.