Quality, Microbiology & Sterilization Services

QMS Services is here to help pharmaceutical and medical device manufacturers meet quality system requirements in this fast changing environment of compliance. Our team can help you develop, implement and maintain quality systems compliant with ISO 13485:2016 as well as CFR 820 or 210. In addition, we offer a full range of technical expertise for your microbiology and sterilization programs. From initial development and validation to optimization or remediation, our expert staff can provide you with the technical assistance you need. Lastly, we are now offering an innovative approach to supporting your routine manufacturing processes. This subscription based service provides you the access and expertise of an industry-trained microbiologist without the need for added head count. This service was developed for virtual to mid-sized medical device manufacturers who generate data but do not need a full time microbiologist.