Quality begins at the design stage. Our team works to clearly understand and capture performance and technical requirements in our product specification and manufacturing documentation. We promote quality at the source and do our best to ensure defects are identified and contained before processing through the next step. With our quality management, we work to comply with the FDA quality system regulation and maintain registration to ISO 13485:2016.
The medical device regulatory environment is complex and having a vigilant partner is key to a successful product. Our team will work with you to satisfy requirements and avoid interruptions due to compliance matters.