Submissions

510(k) / PMA submissions

Consulting

UV-emitting devices and more...

More...

Get more information or request a quote

Our Team

Our staff of technicians can be on-site almost overnight!

Our Team

FDA Listing Consultants

allpicsRobert T. Wagner, CEO, established AEGIS in 1995 after 10 years of in-house service at various medical device producers in Germany and France. Fluent and technically proficient in the four major European languages, he is intimately familiar with both 21 CFR and many foreign medical regulatory entities, and travels overseas on a regular basis to personally meet with clients, offering the best possible guidance on product approval strategies and processes.

bob@fdalistingconsultants.com

865-982-5552

865-381-1808 fax

 

Dr. W. Howard Cyr, Ph.D., Senior Science Associate
Dr. Cyr began his career at FDA in 1974 and retired in 2006 as the Senior Research Biophysicist at the agency's Office of Science and Technology, which is today OSEL (Office of Science and Engineering Laboratories). His fields of specialization included genetics, ionizing radiation and photobiology. He concluded his service as FDA's Cell Phone Czar, and joined AEGIS in January of 2009. Contact Dr. Cyr: howard@fdalistingconsultants.com

 

Ron Denny - Chief Testing Engineer

ron@fdalistingconsultants.com

865-982-5552

865-381-1808 fax

 

Bridgett Van Horn - Executive Administrator

bridgett@americanexportgroup.com

865-982-5552

865-381-1808 fax

 

Susan Mullen - Document Specialist; ISO 9001 Specialist

Susan is an ISO 9001-2008 Certified Internal Auditor well versed on all standards of ISO 9001-2008. She was the Document and Records Control Coordinator for 4.2.3 and 4.2.4 respectively of the ISO Standards and has helped organizations achieve ISO 9001-2008 certification.

sue@fdalistingconsultants.com

954-793-2281

 

 

Our professional staff of technicians is ready to serve our clients' needs by traveling to their facilities with very little prior notice.

 

Contact us for a quote by clicking on the Request Info link or by phone / email. We will be happy to submit a written cost analysis of our services within 48 hours after having received your inquiry.

Phone Phone: 865-982-5552
Fax Fax: 865-381-1808
WWW Link Website: www.fdalistingconsultants.com
Email Email: info@fdalistingconsultants.com