President/Founder, DP Distribution & Consulting, LLC.
Darren Reeves began his career in the healthcare industry in 1988 as an inspector on the floor of a $20 million medical device manufacturer. He worked with that company through tremendous growth and ultimately became vice-president of the then $1.2 billion company. This company included both EtO and Gamma sterilization, both of which Darren was responsible. As Darren’s expertise in medical device regulations and compliance grew, so did his understanding of the complexity facing manufacturers. As a result, he formed DP Distribution & Consulting ® in 2000 to help business leaders with medical device quality and regulatory consulting challenges. Darren was entrenched in the industry during the transition of the FDA GMP to the QS Regulation (QSR) in 1997, which was the beginning of the implementation of design controls and many other quality subsystems. He was over 9 domestic and 7 international device facilities of all types in which he implemented the QSR. Being from Richmond, VA, Darren worked closely with the FDA CDRH in Washington, DC during that time to ensure the proper implementation of the regulation. Darren and his team are now preparing companies for the new transition from the QS Regulation to the QMSR.
