Medical device and implant projects are becoming more and more complex. The importance of making sure that your manufacturing partner has appropriate certification and a strong history of success in the medical industry cannot be overstated. At LaVezzi, quality is more than just a slogan. It’s a way of life. At every point in our high precision machining process, infusing quality is our top priority. And in order to deliver components that precisely meet our customers’ exacting specifications, our quality control facilities and capabilities have to be even better than theirs. This commitment is exemplified by the number of customers who routinely use LaVezzi Precision as a dock-to-stock supplier.
Since your success – and ours – begins with the materials used for the high precision machining of your components, we adhere to a strict process for handling and tracing them.
LaVezzi requires complete traceability of all materials from receipt through order shipment. All material obtained by LaVezzi is stored in a secure area surrounded by an electric fence with tightly controlled access. A raw material rack with an electronic sensor and alarm ensures that the material is accounted for and only accessible by those authorized to handle it.
To verify that the material is per the supplier’s certification, material dispatched to the manufacturing floor is checked 100% with an XRF (X-ray fluorescence) analyzer, which verifies that the chemical analysis is per specification.
Once on the line, material and components are stored and handled to continue to ensure their integrity. We maintain an environmentally controlled production floor that keeps dust out and the right temperature and humidity in. Customized material handling racks with individual compartments prevent any damage to the parts as they move through the production stages.
Throughout the production process, every LaVezzi component or implant is visually inspected to ensure that it is of the highest quality. Deburring under 5-20X magnification is a regular part of the production process. A state-of-the-art Quality Assurance lab utilizing the most sophisticated inspection equipment available ensures that specifications are maintained.
Our commitment to quality is evident not only in our rigorous inspection processes, but also in our certifications and registrations. In addition to ISO 13485:2016 (view certificate) certification, LaVezzi is FDA-registered and GMP-compliant. Our adherence to the requirements of these standards ensures that your product meets your exact specifications.
Request a copy of our Quality Manual or contact us to learn more.