1. Bruce founded Prothro Consulting Group after 28 years of proven success working with venture
backed, mid-sized, and large medical device companies. For the past 18 years, he has held
executive level leadership positions, including Vice President, Global Vice President, and Chief
Regulatory Officer, for rapidly growing entrepreneurial based and large multi-national corporations.
In this capacity, Bruce has led regulatory affairs, quality assurance, quality systems management,
clinical research, and medical affairs functions while managing organizations ranging from just a
few individuals to global networks in excess of 200 people. He has experience in operations and
manufacturing management and general management for surgical products. In addition, he has
validated facilities in both the United States and Latin America and has performed due diligence
for numerous mergers and acquisitions.
Throughout his career, Bruce has leveraged his breadth of experience to help companies drive to
practical, well thought-out solutions that complement both regulatory and compliance objectives
along with commercial initiatives. This background makes Bruce truly unique among regulatory
and quality professionals.
Strategic, Hands-On, Pragmatic, Thorough, Solutions-Oriented, Collaborative, Professional,
Composed, Responsive, Hard Working, Efficient.
These are a just few of the adjectives used to describe Bruce during his career and the very same
attributes that lead to well-designed, well-crafted solutions in the ever-changing environment of
regulatory affairs, quality assurance, compliance, and clinical research.
Under his leadership and guidance, Bruce’s organizations have:
• Developed submission strategies in over 14 surgical specialties
• Supported class I, class II, and class III devices
• Submitted over 140 510(k)s
• Obtained a 98% clearance rate
• Guided complex and unique PMA submissions
• Developed and executed FDA submission strategies for the reintroduction of products
in the US market
• Executed BLAs and strategies for combination devices
• Managed over 100 technical files and dossiers for EU commercialization
• Obtained registrations in over 60 markets including Latin America, China, and Japan
• Submitted over 1,700 registrations and renewals annually for emerging markets
• Developed and implemented quality management systems for small and mid-size companies
• Managed over 30 FDA and notified body inspections without a warning letter or
major observations
• Developed clinical strategies to support new indications
We are Experts. We are Professional. We Roll-up
our Sleeves. We Drive Results in all Stages of
Growth…from Concept to Commercialization.
B R U C E P R O T H R O
512.409.6602
bruce@prothroconsulting.com
www.prothroconsulting.com

2. In addition to his work in regulatory affairs, quality assurance, operations, and clinical research,
Bruce has developed strategies to mitigate risks of off-label promotion, served on corporate
compliance committees, and contributed to the mitigation and resolution of issues arising from
SEC and DOJ investigations. He has developed and led global complaint management, MDR
and Vigilance reporting, corporate audit functions, and implemented UDI across a global
network. He has presented at various conferences nationwide on regulatory and quality assurance
challenges and has represented companies in litigation as a company-designated expert witness.
Bruce’s career in medical devices started at Advanced Cardiovascular Systems and progressed to
KervaVision, ArthroCare, and Smith & Nephew. He has participated in initial and secondary public
offerings, acquisitions and mergers, and was part of the leadership team that steered the $1.7B
acquisition of ArthroCare by Smith & Nephew.
Bruce holds a Bachelor of Science in Chemistry from University of California, Berkeley where he
also played football.
Prothro Consulting Group is dedicated to meeting your needs. We are flexible,
cost-effective, solutions-oriented and responsive. We recognize it is a big world and
many companies have multiple locations. We are available to work virtually, remotely,
and side-by-side. We can be an in-house resource or we can be an off-site consultative
service. In addition to our international work, we have experience on the West Coast,
East Coast, and areas in between.
LEARN HOW PROTHRO CONSULTING GROUP CAN HELP DRIVE YOUR TECHNOLOGY
FROM CONCEPT TO COMMERCIALIZATION.
Call or Email Today.
512.409.6602
bruce@prothroconsulting.com
www.prothroconsulting.com