A true grit story. Several years ago, a client came to PLS with an extremely innovative system of surgical tools for disc nucleus replacement. The client designed each tool for each stage in the surgical steps so the physician would have everything needed in one kit to perform the procedure. We worked alongside our client to develop user requirements and specifications under ISO 13485:2016 and 21 CFR 820 (FDA QSR) regulations. Our client decided to submit for CE marking first. PLS helped generate data and surgical tools to support their clinical trials and CE mark submission. Once the client received the CE mark, they decided to pivot their focus to the US market. PLS’s quality system complies with both European and USA regulations, allowing us to pivot easily to support their US clinical trials