About SBME

SBME is the ultimate partner for medical device developers looking for comprehensive and reliable solutions. Our knowledgeable team fosters collaboration, working directly alongside our clients to help them meet their needs and achieve their goals, ensuring a smooth and efficient experience throughout the process.

Our Mission

Secure BioMed Evaluations operates as an extension of your team. Whether leading a project or supporting specific areas of your team, we seamlessly mesh with your organization.

Our clients appreciate our ability to form a cohesive team working towards commercialization of medical devices and biologics. We take pride in seeing your ideas materialize, whether bringing your concept to market or developing your concept for acquisition.

Linda Braddon – Founder of Secure BioMed Evaluations


Linda Braddon

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.

VP of Engineering

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.

VP of Regulatory and Technical Compliance

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.

VP of Quality

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.

Successes for our Clients

  • K230398 3D Printed Patient Specific Plates
  • K223421 Orthopedic guides
  • K231199 Additive Manufactured Implant
  • K223725 Wound Powder
  • K223418 Additive Manufactured Implant
  • K223059 Spinal System
  • K223024 Patient Specific Cutting Guides
  • K222967 Cannulated Screws
  • K222189 Wound Dressing
  • K221488 Zirconia Dental Device
  • K220498 Collagen Wound Dressing
  • K220357 Patient-Specific Implant
  • K213918 Spinal Instrumentation
  • K213901 Spine – Cervical
  • K213456 Spine – Cervical
  • K213455 C-Arm Radiation reduction K211782 C-Arm Radiation reduction
  • K211592 Ulnar Plating System
  • K210115 Orthodontic Sealant
  • K210090 Spine
  • K202431 C-Arm Radiation reduction
  • K202071 Wound Irrigation System
  • K201287 Spine Implants
  • K200663 C-Arm Radiation reduction
  • K200614 Antimicrobial Cavity Cleanser
  • K200376 Surgical software system for hip arthroplasty
  • K200238 Sterile Cover
  • K193583 Wound Dressing
  • K193280 Dental fixation
  • K192786 Spine
  • K192282 Dental fixation software and surgical guides/splints
  • K191118 Orthopedics – Trauma
  • K190291 Spine – Additive Manufactured Implants
  • K190271 Cavity Cleanser
  • K182010 Wound Dressing – Human Keratin
  • K180962 Dental – Patient-Specific Implants
  • K173814 Spine
  • K172936 Knee Replacement
  • K172857 Hip Arthroplasty
  • K172603 Neurology
  • K170300 Wound covering
  • K162179 Bone plate
  • K161278 Neurology
  • K153613 Neurology
  • K151496 Spine
  • K151462 Spine – SI Joint
  • K150824 Electrosurgical tool
  • K150759 Spine – Cervical
  • K142534 Orthopedics
  • K142531 Spine
  • K142478 Orthopedics
  • K133194 Spine

Bring Your Medical Device to Market Faster & with Confidence

Whether you have questions or are ready to get started, our team of experts is ready to help!