Expert Medical Device Consulting Services

MEDICAL DEVICE PARADIGM SHIFT Feb 2, 2026

As the new QMSR Final Rule Kicks off on February 2, 2026 it is our belief that senior manager leadership, training, and FDA postmarket expertise will all grow in more importance.

The FDA’s QMSR Final Rule goes live February 2, 2026. You have had up to 2 years to prepare, but are you really inspection ready? If you are not sure then the First Step could be a gap analysis that compares what you have versus what is actually required. Then you and your team can fix everything up or you can let us help you fill in the blanks or counter misunderstandings and more importantly train your team. This would also be an excellent time to doublecheck your MDR readiness.

So, in case you don’t already know, here’s an important take home:

The QMSR Final Rule’s status as a regulation (rather than guidance) means it carries legal obligations and deadlines that industry must prepare for

Barry Michael

Founder, Biomedical Commercialization LLC

+1 301.535.4805

JoAnn Fujikawa

Founder, Regulatory Compliance Solutions LLC

+1 610.324.7107

Scientists with Test Tube and Microscope

Meet Barry Michael, ScB, MBA

In Business for Over 20 Years

Under the leadership of Barry Michael, a recognized biomedical commercialization expert, BCL has established a strong reputation for excellence. With extensive experience since earning his Wharton MBA in 1976, Barry has a unique ability to guide both early-stage startups and established corporations through the intricacies of product commercialization.

Our services include project-based and fractional vice-presidential support, focusing on essential areas like strategic planning, marketing, sales, and operations.

Insight-Driven Strategies for Successful Outcomes

With a strong foundation in medical device consulting, Barry offers tailored strategies that help clients overcome development obstacles, navigate regulatory challenges, and ensure a smooth transition to market. We aim to empower you with the insights needed to achieve lasting success.

Mentoring and Speaking Engagements

Alongside project-focused consulting, Barry is dedicated to sharing his expertise. He offers speaking engagements at medical device events and mentoring opportunities, supporting both specific questions and broader organizational discussions.

Schedule Your Consultation Today

Experience exceptional service with BCL. Browse our website to explore Barry’s qualifications and see how our consulting services can meet your needs. Our tailored strategic biotech planning helps align your innovations with business goals, speeding up time to market and boosting commercial success.

Learn more about our comprehensive consulting services and how we can assist you in achieving your business goals. Contact us today.

Contact Details:

Barry Michael