About Us
Over 20 years of combined experience helping medical device companies navigate FDA, ISO, and global regulatory requirements.
Our Mission
We believe regulatory compliance should empower innovation, not hinder it. Our mission is to provide clear, practical, and responsive consulting that helps medical device companies build quality systems they can rely on — and inspectors will respect.
Our Approach
Every engagement begins with understanding your unique situation — your products, your markets, your team, and your goals. We don't apply cookie-cutter templates.
Instead, we build systems and documentation that reflect your actual processes, align with regulatory expectations, and scale with your growth.
Meet Our CEO
Alexander Braun Henderson
Chief Executive Officer
Alexander Braun Henderson is an accomplished professional with extensive experience in medical device regulation, quality assurance, and electronics engineering with over 20 years of experience in the MedTech industry. As the owner and senior Consultant of BraunSolutions Regulatory Group LLC, Braun has provided expert consulting services to small business medical device companies, specializing in US FDA/cGMP,510(k),513(g) submissions, ISO9001, QMSR/ISO13485, FDA Registration and Listing, Device Classification, Internal Audits or GAP Analysis, and UDI/GUDID Labeling Services.
He is also currently serving as the Interim Director of Quality Assurance and Regulatory Affairs for Aspen Laser Systems and Theralight LLC.
His technical expertise includes developing custom QMSR quality manuals, standard operating procedures, and serving as the senior auditor for FDA, OSHA, and EPA regulations at various medical device companies throughout the United States.
Alexander's career spans several leadership roles, including serving as the CEO of Noble Anesthesia-Air, Inc.; Operations and Quality Assurance and Regulatory Affairs lead at LED Technologies, LLC; and Technical Manager and Director of QA & Regulatory Affairs at Access Battery and Power Systems, LLC.
What Guides Us
Clarity
We translate complex regulatory language into straightforward guidance you can act on.
Integrity
We tell you what you need to hear, not just what you want to hear. Honest assessment leads to better outcomes.
Partnership
We work alongside your team as an extension — not as outsiders handing off deliverables.