Ronald Bergeson, RAC

Current

Owner at Bergeson Regulatory Consulting

Past

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

5 more...

Education

University of Arizona
University of Arizona

Recommended

6 people have recommended Ronald

Connections

189 connections

Industry

Medical Devices

Websites

My Website

Ronald Bergeson, RAC’s Summary

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

Some accomplishments that were challenging and personally rewarding are shown here. (Others can be seen in the Experience section below.)

1) Negotiated with the FDA (Director of CDRH and Division Director) to reverse a 10-year old FDA non-approvable decision with no additional data requirements;
2) Prepared my Company for a highly publicized and controversial advisory panel meeting that resulted not only in an unanimous approval by the Panel, but also elicited a very rare and nice compliment from the Panel Chair on the quality and preparation of our presentation.

My goal is to join a device company to create innovative and successful regulatory strategies, clinical studies and submissions. I also provide significant expertise in quality assurance areas, ISO 13485 certified quality systems and 14971-based risk analysis.

Ronald Bergeson, RAC’s Specialties:

Strong negotiation skills with regulatory agencies at the highest levels.

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 2 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