thomasregulatory.com

5613 Tiger Way, 34787, Winter Garden, United States
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5.00
Based on 4 Reviews

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About thomasregulatory.com

★★★Finding a trusted & frank medical device consultant at an affordable rate can be difficult.With rapidly changing regulatory, quality, & clinical evaluation requirements, it can be difficult to keep up.Years ago I started my career & soon realized my passion in regulatory & quality.To cut your regulatory & quality costs over the long term requires the right client-consultant fit. I’ve worked w/ device companies across the country & internationally in training, guiding on varied medical products including low to high risk devices in areas of dental, neuro-surgical, vascular access, ultrasound, stent grafts, sutures, ophthalmic & vision care, biosensors, & wound care among others.Message me for a free consult! ★MY PROCESS★ I'm a hands-on strategy developer, information hunter, life-long learner & connected team player. I seek to improve existing processes for maximum productivity, taking a lean approach to reduce costs.I believe in seeking the most robust & sound regulatory & quality & compliance solutions & strive to find the least burdensome approach within due bounds for clients.I believe in being approachable & transparent in assisting my clients in any concerns.I’m here to help answer your questions & provide guidance in navigating the complex regulatory & quality space.My intrinsic ethics & values instilled in my youth are of the highest caliber & I believe in dialogue,mutual input & respectfully maintaining the relationship intact in disagreements.As I’ve been in this industry for most of my career, I’m confident in my abilities to assist you as I have w/ others.I understand your challenges and how to bring solutions ★CONTACT★ ►[email protected] ►Based in Central Florida USA ▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬ ◆MDSAP◆FDA◆510(K)◆483◆Regulatory Affairs◆Latin America◆Medical Device◆CER◆Internal Audit◆CE Mark◆ISO 13485◆21 CFR 820 QSR◆MEDDEV 2.7 R4◆MDR 2017/45◆MDD 93/42◆Brazil◆ ▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬

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George Mulvaney
US

Thomas Regulatory Let's say Dallas knows his business, Dallas walk me through the process and in a very short period of time had figured out exactly how to handle the FDA issue within a few days all of my issues were resolved. The FDA came back with a ruling that was in my favor because of Dallas. I strongly recommend Dallas if you have issues with the FDA, Dallas knows the ins and the outs of the FDA so therefore has a better insight to fixing your problem I recommend him very highly. George F Mulvaney Robbins instruments

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Michelle Zeek
US

Dallas was awesome in helping us with… Dallas was awesome in helping us with all of our FDA problems. Highly recommended.

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Mike Meehan
US

Tremendous effort and support Tremendous effort and support. Truly led the way in a professional and experienced manner. Dallas' interface with the FDA was key to our successful filings. I would recommend Thomas Regulatory with no reservations!!

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Ungar
FR

"I would like to thank Dallas for all… "I would like to thank Dallas for all the valuable help it has provided us in a relatively short period of time in order to completely redesign our clinical assessment. The result is that we have been able to obtain CE recertification and ISO 13485:2016 certification for our company, which is invaluable for doing business with Europe and other countries in the Middle East. The work accomplished was carried out very quickly without any obstacles, Dallas immediately understood the expectations of our company. Regis Ungar, Manager AKRA DERMOJET, France"

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