About Us
Biomedix Consulting Biomedix Consulting, led by regulatory and quality expert Rob Fritzenkotter, provides specialized consulting services for the medical device, pharmaceutical, and biologics industries. With over 20 years of experience, we help organizations navigate complex regulatory challenges, develop and remediate Quality Management Systems (QMS), and offer expert technical writing for regulatory submissions. Our personalized approach ensures tailored solutions that align with your business objectives, making us a trusted partner in achieving compliance and maintaining high-quality standards throughout your product’s lifecycle.
Rob Fritzenkotter
Technical Data Processing, Drugs, Devices, Biologics
Rob Fritzenkotter is the Founder and President of Biomedix Regulatory Consulting, LLC, a firm dedicated to regulatory compliance, quality management systems, and technical documentation for the drugs, devices, and biologics industries. With over two decades of experience, Rob has built a strong background in technical data processing, regulatory affairs, and quality system development. He is skilled in helping companies navigate FDA, EU, and global regulatory requirements to achieve compliance and operational efficiency. Rob’s focus on risk management and technical documentation supports companies in bringing innovative products to market effectively and in line with regulatory standards.
Rob Wester
Biostatistics, Quality Assurance, Clinical Data Management, Change Management
Rob Wester is a seasoned consultant with over 20 years of experience in epidemiology, biostatistics, and health information technology. He specializes in managing complex, high-risk projects, focusing on quality assurance, decision support, and data analytics that drive improvements in system lifecycle management and cost savings. Rob’s leadership fosters collaboration and trust, enabling successful change management and system interoperability initiatives. His expertise spans both technical roles and leading high-performing teams during critical public health events. Rob holds advanced degrees in Biostatistics/Epidemiology and Education, along with a Bachelor’s in Biology.
Mike Begala
Quality Audits, Regulatory Compliance, QMS implementation
Mike Begala is a Senior Consultant with extensive expertise in FDA Quality System Regulation (21 CFR Part 820), ISO 13485 implementation, and global regulatory compliance. He is a recognized expert in FDA QSR, known for his work in training, audit preparedness, and responding to FDA Form 483 observations. Mike has hands-on experience conducting gap audits and managing compliance across international regulatory systems, including Europe, Canada, and the USA. He has worked with a wide range of medical devices, including cardiovascular, orthopedic, aesthetic, implants, IVDs, and sterilized devices. Mike holds a Bachelor of Science in Physics from the University of Texas at Austin and a Master of Science in Management from the University of Alabama in Huntsville, which further supports his broad technical and managerial expertise