Experienced in Med Device

At Camco, we bring a wealth of experience and expertise to the realm of medical device validation. With a track record of successfully performing numerous process and device validations over several decades, our team is well-versed in the intricacies of this critical aspect.

We offer comprehensive turnkey validation services to ensure the highest levels of product quality and regulatory compliance. Our validation activities encompass a wide range of essential processes, including TMV (Test Method Validation) and Gage R&R (Repeatability and Reproducibility), IQ/OQ/PQ (Installation Qualification, Operational Qualification, and Performance Qualification), PPAP (Production Part Approval Process), Cpk/Ppk process capabilities, FAI/FAIR (First Article Inspection/Report), and SPC/Data Collection (Statistical Process Control/Data Collection).

Additionally, we are highly knowledgeable and well-versed in FDA 21 CFR Part 820, which outlines the quality system regulations for medical devices. This expertise allows us to navigate the regulatory landscape with confidence, ensuring that our validation activities align with the stringent requirements set forth by the FDA.

By entrusting your medical device validation needs to Camco, you can have peace of mind knowing that our experienced team will handle the process with meticulous attention to detail and adherence to regulatory standards. We are committed to delivering validated products of the highest quality, enabling you to bring safe and effective medical devices to market.