Most medical device companies are either ISO-13485 certified, or are working towards certification. We have worked within numerous ISO-13485 certified companies, and we have played key roles in establishing ISO-13485 certified quality systems. We understand quality and take it seriously.
However we intentionally do not have our own quality system. We work within your quality system if you have one. And if you haven’t yet established a quality system, we perform and document our work in a way that will fit well within FDA and ISO compliant systems, including those of our manufacturing partners. This nimble approach enables us to satisfy your requirements smoothly and efficiently.
However we intentionally do not have our own quality system. We work within your quality system if you have one. And if you haven’t yet established a quality system, we perform and document our work in a way that will fit well within FDA and ISO compliant systems, including those of our manufacturing partners. This nimble approach enables us to satisfy your requirements smoothly and efficiently.
