Our Clients

``I wanted to thank you again for the help you and your team provided Weslacova. As I mentioned a few weeks ago, we experience our first FDA audit. That audit went will with no findings. The auditor had very little to say negatively about our QMS.

Last year during our third party, BSI audit, the auditor hit us with 3 majors NC’s and 4 minors. That was one of the reasons that I made the decision to contract with you and your team. Tuck was great to work with and offered a several changes that we have implemented into our QMS. We still are reviewing his many notes to make sure that we haven’t missed anything.

We had our annual, 2.5 day surveillance audit this week with BSI and were issued no new NC’s. They were able to close the 4 minors from last year as well. I could tell from the areas that he looked into that we would not have had such a successful audit, it had not been for your help.

THANK YOU again for all that you did to make Weslacova a better company. I have a few projects on the horizon that may require your expertise. I’ll not hesitate to reach out once we get to the point of getting those project off the ground.``

SCOTT MAUNEY

President/CEO

``We all want to thank you for your time with us today. This was one of the most useful exchanges that we have had, as it was very practical. Lots of times we are searching for the sweet spot to be compliant but not waste unnecessary time, resources, and money on things that are not adding value. Your approach is right on point for those objectives. Besides that, everybody feels comfortable discussing these things with you. Thank you for the help. And thank you for respecting what our business has done thus far. It is refreshing.``

SUSAN JOHNSTON

Chief Executive Officer & Director, Regulatory Affairs

``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 SPANGLER

President, 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 CARICO

Quality 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 STORM

Operations 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 FLISS

Welmed 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 DONOHUE

President and Executive Director, GENEDGE Alliance