Qualification and Validation
Medical device product qualification and validation refer to the process that demonstrates a medical device and its components meet regulatory, safety, and performance requirements before introduction to the market. This process ensures that the device is safe, effective, and compliant with applicable standards and regulations.
With ISO 13485-certified and FDA-registered facilities, Schivo is positioned to offer fully qualified and validated components, sub-assemblies, and assemblies to medical device OEM customers around the world.
Schivo tests and validates its production processes with ISO-accepted installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) methodologies prior to production. Then, each part‘s production data is recorded, tracked, and stored in the company’s manufacturing management platform for future reference and assurance it meets or exceeds specifications. This rigorous quality assurance process ensures that Schivo’s products are made exactly to OEM requirements.
It also means that OEMs can mitigate risk and forego pre-production testing and validation of Schivo’s parts and assemblies. The capability to drop in components in the OEM’s assembly workflow saves time and improves productivity.
