The Request
One of the Big 3 contacted RI in need of a vendor that could supply a custom-built protective accessory for its new line of cassette-sized detectors. The customer had a drawing set and product requirements defined and ready for RI to build to print. This project was to be completed in a timely manner, with tight tolerances and at a favorable cost. Reina was prepared for the challenge and engaged with this large domestic OEM to complete the project.
Our Approach
Our quality system – guided by ISO13485-2016, IEC 60601, FDA and EU MDR requirements – lays a clear foundation for success. In this case, our team of engineers first reviewed the customer’s drawings and product requirements. For this print build opportunity, our team was able to identify some potential engineering deficits in the design that would have been impactful to the final product. After some discussions with the customer, we were able to put a development plan in place which included a series of gated reviews and customer approvals to ensure the project outputs matched the customer’s inputs. This plan provided a mutually agreed upon process to build a product that, in the end, exceeded the customer’s expectations.
When Quality Counts
RI is a bona fide and certified medical device manufacturer. This means we adhere to the strictest global regulatory requirements when designing, producing and supplying products. This is a key attribute when demanding customers evaluate potential suppliers. The specific OEM partner is a global leader in the medical device arena and only partners with vendors that can supply products with demanding specifications and high volumes at a great price.
The End Result
After years of supplying these goods to this large and trusted partner, RI is proud to say we have had no returns, complaints, nonconformities nor any other quality issues, earning a 100% supplier score at every review. Consistent quality and strict manufacturing processes have made Reina the first choice for all the Big 3 OEMs for accessories development and we’re proud to have retained this customer as one of our valued accounts.
Related Posts
Please take a look at some of our other success stories where we had to think outside the box to ensure our customers' needs were met and the perfect products could be provided.
