CCS is your full-service solution to design control, software validation, and software development. We provide support from custom medical device software development to independent testing and 510(k) submission services. Dan Olivier has been hired by the FDA to provide software training for FDA investigators and also to serve as an expert witness.
CCS Regulatory and Quality Compliance Experts:
CCS consultants are experts in providing regulatory and quality compliance services for industry leading medical device and pharmaceutical companies. We leverage our industry experience through use of proven libraries of quality system procedures, design control specifications, and process validation protocols to facilitate compliant solutions to quality system challenges.