HOW DP HAS HELPED OTHERS
``I wanted to reach out and say thanks a million for GENEDGE MEP providing Darren Reeves as a resource to the system for FDA advice. Darren has been awesome and very quick to respond to our clients. I passed several clients this week to Darren and never worried about them because they were in great hands. One client called me and was so helpful because of Darren’s advice he can get product in South Carolina now.``
CHUCK SPANGLERPresident, SC Manufacturer’s Extension Program
``This was the first time the FDA (or anyone) has thoroughly gone through the SSV validation. The auditor spent the better part of two days going through the data and had only one question. Thank you for organizing the validation data in a way that made it easy to understand! It is very much appreciated.``
PAUL CARICOQuality Assurance Manager, Aplicare, Inc.
``We have been very satisfied with not only the quality of service, but the tailored approach DPDC offers to meet our needs.. DPDC is always only a phone call away and DPDC has answered our questions and resolved concerns promptly and effectively.``
RANDY STORMOperations Manager, Pedigo
``We feel that Darren's experience and industry wisdom is a necessary resource for our company. For several weeks, and under his direction, we completed significant quality management system training and process development. Process Owners at all locations have been assigned responsibilities for their respective areas and are also being specifically trained to the requirements of all U.S. Federal and International requirements applicable to their responsibilities. We are very pleased at the progress thus far and are looking forward to the long-term, systemic, continuous improvements being made.``
DAN WINNETT, ESQ.Greystone Pharmaceuticals(now The Wound Care Co. LLC)
``I really appreciate your time and sharing your expertise regarding medical device industry. You provided excellent and valuable information, and more importantly clarify many doubts that we had. I will say that we are better prepared now to assist our manufacturers in PR to face the emergency of COVID-19 and help minimize health problems.``
RAMON VEGA ALEJANDRO, P.E.DBA MDAP/Industry 4.0 Program Manager
``Welmed has used Darren as our FDA consultant for more than two years now — and I cannot foresee anything in the future that would make me change this direction. We want to do things the right way, but also the smart way. It is Darren’s balance of business and FDA needs that I respect and admire the most. In my opinion, your company could not hire a better consulting firm.``
DAVE FLISSWelmed Inc.
``Re: EXPERIENCE WITH MEDICAL DEVICE 510K PREMARKET NOTIFICATION: Darren and his team supported 38 MEP centers during our Response programs for COVID-19. He is a highly trusted third-party for Genedge, having provided the service to our client base now for 20 years.``
BILL DONOHUEPresident and Executive Director, GENEDGE Alliance
Below is a sampling of the 200+ clients that DP has helped with quality plans, 510(k)s, staff training, and more. Contact DP Distribution & Consulting ® and let us help you get the most from your quality assurance and regulatory affairs activities.