Ronald Bergeson, RAC

Current

Owner at Bergeson Regulatory Consulting

Past

VP, RA/QA at ReVision Optics, Inc.
Director, RA/QA at HealthTronics, Inc.
VP, RA/QA at Medstone International

5 more...

Education

University of Arizona
University of Arizona

Recommended

7 people have recommended Ronald

Connections

217 connections

Industry

Medical Devices

Websites

My Website

Ronald Bergeson, RAC’s Summary

My interests:
• Creating regulatory strategies for US and WW (EU, Japan, Taiwan, S & L America);
• Developing Clinical protocols, investigational plans, study management and budgeting;
• Creating certified Quality Systems (QSR, ISO 9001 and 13485) and training for efficient operation;
• Product certifications (CE mark, UL, ETL, CSA).

Some challenging and personally rewarding are shown below (others can be seen in the Experience section below):

1) Negotiated with the FDA (CDRH and Division Directors) to reverse a 10-year old FDA non-approvable decision with no additional data requirements;
2) Helped prepare for a highly publicized and controversial advisory panel meeting that resulted in unanimous approval, and also elicited a very rare and nice compliment from the Panel Chair on the quality of our presentation.

My goal is to join a device company to create successful US and worldwide regulatory strategies, submissions and clinical studies. I also provide seasoned expertise to develop quality systems and ISO 14971-based risk analysis procedures.

Ronald Bergeson, RAC’s Specialties:

• Strong negotiation skills up to the highest levels of regulatory agencies;
• regulatory due diligence for M&A;
• efficient new product development programs;
• clinical protocol and trial development and execution

Product experiences:
Implantables, DME, disposables, sterile product, IVDs, radiological, software driven/embedded.

Product areas:
cardiovascular, urological, OB/GYN, gastroenterology, general & restorative, ophthalmic, anesthesia

Ronald Bergeson, RAC’s Experience

Owner

Bergeson Regulatory Consulting

(Medical Devices industry)

June 2005 — Present (4 years 7 months)

• Regulatory and product development strategy & submissions
• FDA QSR compliance and ISO 13485 certification
• Liaison with the FDA (clinical and IDE and marketing submissions; compliance issues)
• Quality systems and manuals for new and expanding medical device companies
• Product and quality system certification
• FDA clean-up

Ronald Bergeson, RAC’s Education

University of Arizona

MSc , Toxicology/Chemistry , 1900 — 1900

Graduated with honors
Authored and defended graduate thesis: "Distribution of 3,4,4'-tricholorcarbanilide in the Rat" (active anti-bacterial agent in "Dial Soap") sponsored by Proctor & Gamble.

Activities and Societies:

Phi Kappa Phi
University of Arizona

BS , Microbiology/Chemistry , 1900 — 1900

Graduated with honors ("High Distinction")

Activities and Societies:

Phi Kappa Phi

Additional Information

Ronald Bergeson, RAC’s Websites:

My Website

Ronald Bergeson, RAC’s Interests:

New technologies and applications, novel and efficient regulatory pathways, efficient & effective quality systems, Dale Carnegie Training Human Relations, downhill skiing, hunting & target shooting, church ministries