Many times, a company has a dream that requires a long journey and following strict guidelines to make it a reality. Recently, we helped a medical device developer with their prototypes to help get them through their medical trials. After they had cleared their FDA 510(k) hurdles and became eligible for manufacturing their device, Paragon was there to support their dream. Being that the customer was a design house, they lacked the critical infrastructure needed to track their manufactured medical devices as required by their governing agency. Que Paragon Manufacturing Corp to the rescue.
Working with the customer’s engineering and operations group, we were able to put our expertise, and our ISO:13485 certification, to good use by creating their needed infrastructure pieces. We created the documentation path needed for the required build records and integrated it into the evolving build process. Once the build process was set and box-build manufacturing kicked off in full force, managing the manufacturing and product tracking documentation to the required strict regulatory standards no longer became a worry for the customer as we worked with their teams to drop ship and support product as an extension of their company. Whenever an order came in, we built and shipped it out, creating and updating the product documentation. Whenever a change order came in, the product and associated documentation were again updated. When product service, both external and in-house, were needed, we also managed the adjustments to the documentation. It evolved into a very smooth and integrated process for them as they leveraged our manufacturing expertise and documentation infrastructure to supplement theirs, completing the circle from sales, to product delivery, to support, and to additional orders.
Being there to aid the customer is what Paragon Manufacturing Corp is about. We can carry the customer’s dream to its next step and be that critical manufacturing component that is so often missing from most design houses. In this case, not only did we act as a guide to our customer, we became a key structural piece that allowed them to move their product from a dream and into a reality.