QES Medical LLC helps medical device companies solve quality and regulatory matters, and achieve medical device software compliance.
We have vast experience developing software life cycle processes and activities in conformance with applicable regulatory requirements, including IEC 62304 and the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
Are you interested in learning more?
Contact us today by booking a free introductory consultation, so we can explore whether there’s anything we can do to help you from the QA/RA/SW consulting standpoint.
We look forward to hearing from you!
QES Medical Team