Process Validation for Medical Devices
Laserage is a leader in laser processing and medical device process validation. To meet complex device and component needs for businesses around the world, we offer precision tube cutting, laser scribing, drilling, and welding services. Throughout all manufacturing processes, extensive testing, prototyping, evaluation, feasibility studies, and process validation are done to ensure optimal performance and safety.
What is Process Validation?
Process validation is a critical step in the development of tools and, subsequently, medical practices in doctors’ offices, clinics, and hospitals worldwide. To ensure the safety and efficiency of highly sensitive products such as medical components and devices, validation is necessary to prove that the manufacturing processes involved are able to deliver consistently reliable results.
To establish a process that consistently delivers quality products, data must be collected and analyzed throughout the entire manufacturing lifecycle, starting with initial design. Good Manufacturing Practices (cGMP) standards and the United States Food and Drug Administration (FDA) both require process validation in order to monitor and regulate the quality of medical device design and production.
Used at different times throughout the manufacturing process, three main stages of medical device process validation help engineers and manufacturers create the best possible final product: 1) process design, 2) process qualification, and 3) continued process verification.
United States FDA Process Validation Guidelines
The FDA defines process validation as “establishing documented evidence which provides a high degree of assurance that a specific process consistently produces a product meeting its predetermined specifications and quality attributes.”
These explicit validation and verification requirements are laid out in the FDA’s Code of Federal Regulations Title 21 part 820, commonly known as 21 CFR 820.
In 21 CFR 820, the FDA calls for signed and dated documentation approving the validation of processes and major equipment in accordance with established procedures. These guidelines ensure that manufacturers in facilities such as ours monitor their processes and meet universal industry requirements.
Medical Device Validation at Laserage
Our expert team at Laserage works to manufacture lifesaving medical device components every day. It’s a responsibility we take seriously every step of the way, from pre-market validation all the way to eventual re-validation of established practices.
All laser cutting, laser drilling, and laser welding operations at our facilities comply with cGMP (21 CFR 820) and are supported by our sophisticated in-house quality management system.
To learn more about our compliance, on-site validation testing, and medical device process validation, download our new eBook or reach out to one of our specialists today.