About SBME

Founder | President

Linda Braddon, Ph.D., CEO and founder of Secure BioMed Evaluations (SecureBME / SBME), works with both emerging and established companies to provide regulatory, quality and technical support to both the medical device and biologics industry. Dr. Braddon holds a bachelor of science in engineering from Mercer University, School of Engineering along with a master of science and a Ph.D. in mechanical engineering with a specialization in bioengineering from Georgia Institute of Technology. She has served as a National Science Foundation fellow at both Duke University and Georgia Tech and won the 2009 Women in Technology Small Company “Woman of the Year” award. Additionally, Dr. Braddon is on several industry specific boards to keep abreast of changing currents.

SBME’s Vice President of Engineering for has over 25 years of experience with both small / emerging medical device companies. Prior to joining SBME, she was division Vice President of engineering and Manufacturing for Wright Medical following the acquisition of Cartiva, Incorporated.  During this time, she led the development of a synthetic cartilage hydrogel, the first new material approved by the FDA for orthopedic applications since 1999 via the PMA pathway.

She has extensive experience and expertise in medical device development in R&D, Engineering, and Manufacturing capacities, served as a subject matter expert in numerous FDA inspections and notified body audits, and is an inventor on patents related to orthopedic instrumentation, automated injection systems, and localized radiation delivery systems. She earned a Bachelor of Science degree in Mechanical Engineering from The Georgia Institute of Technology in 1998 and was inducted into the Georgia Institute of Technology’s Council of Outstanding Engineering Alumni in 2004.

SBME’s VP of Regulatory and Technical Compliance began her scientific career studying biochemistry in college and working as a summer intern for Brunswick Biomedical as a chemist in assay development and validation. She graduated from Denison University with a B.S. in Biochemistry in May 2002 and started work on her Ph.D. at the University of South Carolina the following Fall and successfully defended her Ph.D. in Analytical Biochemistry with a project focusing on the Identification of Low Molecular Weight Advanced Glycation Endproducts in Diabetic Serum under the mentorship of Dr. John W. Baynes.

After earning her Ph.D., she was selected as the Postdoctoral Fellow in Clinical Chemistry at the Vanderbilt University Medical Center where she gained clinical experience in Diagnostics and Laboratory Medicine in the Pathology Department. In her spare time as a Fellow, she conducted clinical research in the areas of breast cancer biomarkers and diagnostic panels for sepsis using procalcitonin. After her Postdoctoral Fellowship, she was appointed a position as a Scientific Reviewer in the Office of In Vitro Diagnostic Devices and Radiological Health at the FDA, where she quickly became a Product Specialist and lead several teams and regulatory initiatives, such as using HbA1c to diagnose diabetes.

SBME’s VP of Quality holds a Bachelor’s of Science in Industrial Engineering Technology and a Master’s of Science in Quality Assurance. She is an experienced ASQ Certified Quality Engineer since 2003 as well as an ASQ Certified Quality Auditor since 2012. She brings twenty-five plus years of diverse hands on and leadership experience for companies in the medical device industry supporting activities from product conception through commercialization. She is experienced in implementing and leading inspections for Quality Management Systems compliant to FDA, ISO, MDSAP and EU MDR regulations. She also has extensive experience with emerging start-ups from initial quality system implementation to acquisition by large strategic partners including integration of quality systems.

SBME’s VP of Quality has been responsible for quality control, quality assurance, post market and engineering teams with various small and large companies including creating, merging, or remediating Quality Management systems. She is adept at managing and supporting daily and project specific tasks to ensure product quality requirements are met throughout the life cycle of the product including design, clinical, manufacturing and post market requirements. Her unique leadership and audit leader style facilitates open, compliant communication to drive results in support of a common goal.