Medtronic – “Medtronic’s device re-registration in China coincided with the release of the updated version of ISO 10993-11, which contained a more detailed discussion of testing guidance for products contacting circulating blood. This raised several questions by the China State Food and Drug Association (SFDA), which were addressed by a Walker Downey & Associates, Inc. Expert Opinion. The rapid and effective response by Walker Downey & Associates, Inc. helped us to address the issues to the mutual satisfaction of SFDA and Medtronic and brought a much needed clarity to the even broader issue of conducting anecdotal/retrospective animal testing when pertinent human safety data already exist.” Peter W. Urbanski, Principle Scientist, Physiological Research Laboratory, Medtronic
BioControl Medical – “We have been working with Walker Downey & Associates, Inc. on our most recent project, an active implantable device for treatment of heart failure, on aspects of toxicology and biological suitability. We have enjoyed the short response time, professionalism and good spirit, in a matter that saved us a very long time and lot of money.” Avraham (Rami) Biran, PhD, VP Clinical and Regulatory Affairs, BioControl Medical Ltd.
BioSyntech Canada Inc. – “Walker Downey & Associates, Inc. prepared a Toxicological Risk Assessment (TRA) for a product that is quite unique. Their wide expertise in toxicology as well as the regulatory environment was evident, and they delivered a rigorous and thorough risk analysis with an obvious eye towards regulatory agencies. Their opinions were backed by evidence-based data, and when gaps in the data were identified, guidance was provided for appropriate studies. The toxicologist responsible for our project welcomed feedback and was always available for discussion. Overall, we were very satisfied with Walker Downey & Associates, Inc. work, timeliness and customer interactions.”
Biolife LLC (Letter to the Project Team) – “One of the major objectives we set out to accomplish this year was to obtain FDA approval to our first 510(k) submission. Today, we received from the FDA their signed approval to our 510(k), the primary implication of which is to acknowledge that our device components, which are quite new for medical applications, are considered safe and effective. As important, this initial 510(k) now provides a platform from which we can rapidly expand our product uses through new 510(k) applications. While this was simply an outstanding achievement on the part of everyone involved in preparing the submission, the contributions from our consulting toxicologist Dan McLain (www.walkerdowney.com) were indispensable. Congratulations on a significant accomplishment that was done extremely well, and as soon as the rest of the team gets back to town... we will celebrate!!! Thank you for all your help and effort.” Douglas R. Goodman, President & CEO, Biolife LLC, Florida Company of the Year -- Governor's Award.
MiMideX Group – Just a brief note to thank you for your contribution to our FDA meeting. It was a pleasure meeting you and having your excellent counsel during our review meeting. I look forward to working with you on the numerous projects we have in our future. Parker H. Petit, Chairman/CEO, MiMedx Group