Quality, Microbiology & Sterilization Services
QMS Services is here to help medical device and pharmaceutical 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. Please see our Subscription Services page for additional details.
Jennifer R. Asleson
Jennifer has over 25 years of experience in the regulated medical device and pharmaceutical industries. In addition to extensive knowledge of ISO 13485 and ISO 9001, Jennifer has considerable experience with the implementation and continued compliance of numerous AAMI Standards including:
- AAMI/ISO 11135
- AAMI/ISO 11137
- AAMI/ISO 11737
- AAMI/ISO 17665
- ISO 14644
Jennifer gained valuable insights into the manufacturing and utilization of biological indicators as well as process challenge devices during her years at SGM Biotech. Her recent time as a microbiology technical expert for BSI provides insights from the Notified Body perspective for all classes of medical devices.
When not working, Jennifer performs with several local symphony orchestras and follows Major League Baseball. She enjoys her working in her greenhouse and exploring this wonderful country’s public lands and parks, with an emphasis in paleontology.
Jennifer R. Asleson
Jennifer has over 23 years of experience in the regulated medical device and pharmaceutical industries. In addition to extensive knowledge of ISO 13485 and ISO 9001, Jennifer has considerable experience with the implementation and continued compliance of numerous AAMI Standards including:
AAMI/ISO 11135
AAMI/ISO 11137
AAMI/ISO 11737
AAMI/ISO 17665
ISO 14644
Jennifer gained valuable insights into the manufacturing and utilization of biological indicators as well as process challenge devices during her years at SGM Biotech. Her recent time as a microbiology technical expert for BSI provides insights from the Notified Body perspective for all classes of medical devices.
When not working, Jennifer performs with several local symphony orchestras and follows Major League Baseball. She enjoys her working in her greenhouse and exploring this wonderful country’s public lands and parks, with an emphasis in paleontology.
Contact
We look forward to hearing from you; first call is free. If we can’t help you we will provide a list of others who can.