Medical devices are unique in that a malfunctioning device can be the difference between life and death. For that reason, the Food and Drug Administration has strict regulatory requirements that medical devices must meet. Known as “medical device validation”, the process for ensuring the proper design and function of these lifesaving devices applies to the development, production, and sales of the devices. In other words, validation activities include all demonstrations that medical devices must meet the FDA’s performance and safety standards.
Steps Involved in Medical Device Validation
The FDA allows for a bit of flexibility in how manufacturers achieve validation, once the design of the device has been verified. However, irrespective of the type of medical device, the following activities will be required:
- Each manufacturer will establish their own procedures for validating the device
- Each device must be manufactured under defined operating conditions
- All devices must conform to defined user needs and intended uses. Testing of production of the units shall be performed under simulated use or actual use conditions.
- Manufacturers must maintain a Design History File which includes methods used to validate, and the individual overseeing the validation.
- There are also protocols for methodology to demonstrate that the equipment being used in the manufacturing process will offer a high degree of quality assurance such that production processes will consistently manufacture products that meet quality requirements. Such protocols often used are IQ, OQ, PQ:
- Installation Qualification (IQ) verifies that an instrument or unit of equipment being qualified (as well as its sub-systems and any ancillary systems) has been installed and configured according to the manufacturer’s specifications or installation checklist.
- Operational Qualification (OQ) involves identifying and inspecting equipment features that can impact final product quality.
- Performance Qualification (PQ) is the final step of qualifying equipment. In this phase, the qualification and validation team verifies and documents that the user requirements are verified as being met.
Who is Responsible for Medical Device Validation?
It is up to the manufacturer (OEM) to assume responsibility for the safety and proper function of medical devices. To that end, most companies appoint a high-level Quality Control employee to manage the validation process.
Whoever is selected to construct and oversee the validation activities needs to have a thorough understanding of all applicable regulations. Keep in mind that regulations require that the design of the device not only meets user needs but accomplishes the desired function. To put it another way, the individual tasked with overseeing validation activities will be in charge of confirming that their company built the right device for its intended use.
Benefits of Manufacturing Medical Devices in Mexico
Nearshore manufacturing of medical devices, when performed by an established, and reputable contract manufacturing partner can save time and money. However, due to the strict regulations and quality standards governing medical devices, it’s essential that you select a contract manufacturing partner with proper engineering resources that specializes in medical device manufacturing.
Working with an FDA Registered contract manufacturing partner in Mexico offers benefits including:
- Trained, affordable workforce
- Close proximity to the U.S.
- Lower shipping costs
- Greater oversight
- Tax benefits
- Faster production-to-market times
- Less vulnerable to supply chain disruptions
- Less risk of Intellectual Property theft
- Free trade agreement with Mexico
Indeed, medical device manufacturing in Tijuana allows you to reap the benefits of savings, without sacrificing oversight and quality control due to distance.
Learn More About Medical Device Manufacturing in Tijuana
In 2022, Coastline International celebrated 40 years of success in nearshore medical device manufacturing in Mexico. Coastline International boasts an operational capacity of more than 50,000 square feet and 4 separate ISO Class 8 cleanrooms in facilities built to U.S. standards. As a privately owned, San Diego, CA-based U.S. corporation, Coastline International specializes in medical device, electronics, aerospace, and consumer goods manufacturing. To learn more, send us a message or call 888-748-7177.