Lab Developed Tests (LDT):
We have assisted many LDT manufacturers in preparing technical specifications for FDA premarket submissions (510ks) and in establishing Quality System Regulation (QSR) compliant quality systems. Our experience and proven sample procedures and specifications simplify the implementation of quality systems and ensure compliant solutions.
Human Factors in Engineering is receiving increased emphasis within the medical device community. Increased importance is being placed due to the growing number of incident reports and recalls involving usability errors. Ensure your product is not only safe & effective but easy to use by taking advantage of our experience and proven methods. Increase usability and ensure compliance with our templates and procedures.