Using in-house expertise and our network of experts, led by Brian Murphy, B.Eng., PhD, ClinDatrix offers consulting expertise in the following areas of medical device design and development:
Structured Engineering Development
Structured engineering development is the best professional method for developing medical devices. We can review a client’s entire SOP system and recommend upgrades to provide better design control and design verification and to ensure that design validation is properly performed on pilot production units. Our experience and expertise can be used to improve design review processes, engineering documentation systems, device master records (DMRs), technical files and post-market surveillance. FDA QSR, ISO 13485:2003, ISO 14971.
Our clients call on us to serve as an independent third-party design reviewer.
We can evaluate the practicality of new technologies in the fields of electronics; ECG, EMG and EEG signal analyses; software; mechanics; hydraulics; optics; plastics; materials; bio-compatibility; user interfaces; power supplies; electrical safety (IEC60601-1); and systems engineering.
We can provide expertise in patent research and market research that requires an understanding of the medical device industry as well as the various technologies employed in the industry.