Linda Braddon

Linda Braddon

Bio

Linda Braddon, Ph.D., President, Secure BioMed Evaluations (SecureBME / SBME) works with both emerging and established companies to prove 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.

Dr. Braddon founded Secure BioMed Evaluations to provide strategic support to the medical device community. Over time, the support provided to clients expanded from technical support to a full-service firm which supports clients in all phases of the commercialization process. SBME does not just work as an outside consulting firm but truly integrates into the client company as an outsourced advocate. Under Dr. Braddon’s leadership, the SBME team puts customer service and project results at the forefront of all projects. By teaming with SBME, clients can avoid costly pitfalls in bringing their medical device to market faster. Fostered by the extensive regulatory and quality experience of the SBME team, clients are always working under best practices whether it is assessing risks, execution of validation testing, preparation of regulatory submissions, or audit preparation and execution. After 20 years in the industry and a vast array of client projects, Dr. Braddon’s professional experience includes extensive work with devices in areas of orthopaedics, dental implants, ophthalmology, respiratory, urology, hydrogels, dura mater substitutes, wound coverings, orthotic devices, and antimicrobial agents. Dr. Braddon and her team works closely with clients to ensure that the end is always kept in mind whether that is exit after clearance, full commercial distribution, or anything in between.

Services

Linda’s primary areas of expertise include regulatory submissions, regulatory compliance, due diligence support, strategic planning, and expert technical strategy. Linda also ensures the SBME team is of the highest quality in both customer service and technical competency for outstanding client experiences and project success.

Regulatory Support
  • Remediation of FDA warning letters and 483s
  • Strategic regulatory planning
  • Due diligence of regulatory issues for acquisitions
  • Pre-submission applications
  • Request for Designation 513(g)
  • FDA clearances including additional information request support
  • CE Marking
  • Design and execution of testing validation plans
Quality Support
  • Gap analysis for acquisitions, remediation of deficiencies, and best practices application
  • Technical support during quality audits
  • Implementation and maintenance of quality documentation
Other
  • Strategic project planning to meet client goals
  • Management of vendors for efficient execution of project plan
  • Regulatory, quality and technical due diligence
  • Regulatory, quality and technical liaison for acquisition scenarios
510k Applications – Public Domain
  • K133194
  • K142478
  • K142531
  • K142534
  • K142537
  • K150348
  • K150759
  • K150824
  • K151462
  • K151496
  • K153613
  • K161278
  • K162179
  • *Many other successful 510(k) applications as the ghost writer – Not disclosable
General Support – Client not specified for confidentiality
  • Recall – Orthopaedic companies
  • Recall – Biologic company
  • 510(k) Additional Information Request support – various
  • Expert Legal Witness
Ph.D. Department of Mechanical Engineering from Georgia Institute of Technology Atlanta, GA
  • Graduation Date: September 1997
  • Specialization: Bioengineering
  • Thesis: “Development of a Tissue Engineered Vascular Construct with Fibroblasts, Endothelial Cells and a Biodegradable Mesh”
  • Honors: Bioengineering Graduate Fellowship Program
Masters of Science in Mechanical Engineering from Georgia Institute of Technology Atlanta, GA
  • Graduation Date: March 1994
  • Specialization: Bioengineering
  • Thesis: “Material Property Testing of a Collagen-Smooth Muscle Cell Lattice for the Construction of a Bio-Artificial Vascular Graft”
  • Honors: NIH Training Fellowship
Bachelors of Science in Engineering from Mercer University, School of Engineering Macon, GA
  • Graduation Date: May 1991
  • Specialization: Bioengineering
  • Honors: Tau Beta Pi Honor Society, Presidential Fellowship, NSF Research for Undergraduates, 1989 and 1990, Dean’s List
  • NSF Research Fellow 6/90-9/90 Duke University Durham, NC Research for Undergraduates in Biomedical Engineering Dept. Project: Studied protein absorption on polymer films for use in evaluation of thrombi formation on artificial vascular grafts.
  • NSF Research Fellow 6/89-9/89 Georgia Institute of Technology Atlanta,GA Physics Department. Project: Established technique for parahydrogen synthesis for use in high energy reaction studies.
Publications* and Patents
  • 5/97 Patent Co-inventor U.S. Patent 5,981,826 (Ku, Braddon, Wooten): Polyvinyl alcohol cryogel: The development of a novel production method for polyvinyl alcohol for use as soft tissue replacements.
  • Braddon, LG, Karoyli D, Harrison DG, and RM Nerem. “Maintenance of a functional endothelial cell monolayer on a Fibroblast/Polymer Substrate under physiologically relevant shear stress conditions.” Tissue Engineering (Mary Ann Liebert, Inc.) Vol 8, Number 4, 2002.
  • Greer LS, Vito RP, RM Nerem. “Material Property Testing of a Collagen-Smooth Muscle Cell Lattice for the construction of a Bioartificial Vascular Graft,” ASME Advances in Bioengineering (Askew, M.]., ed.), BED-Vol 28, pp. 69-70, 1994.
  • B.S. Kelley, L.S. Greer, KL. Blankenship and C. Delk. “Computer Model and Software Package for the Prediction of Lumbar
  • Stress Levels During Work Place Activities,” 10th Southern Biomedical Engineering Conference Procedures, 200- 203, 1991.
  • B.L. Potter, L.S. Greer, D.S. Walker, S.S. Saavedra, and WM. Reichert, “Multimode Multilaser Coupling into Polymer Thin Film Waveguides,” Chemical Biochemical and Environmental Fiber Sensors II. R.A Lieberman and MI.Wlodarczyk, Editors, Proc. SPIE. 1368, 251-257, 1991.
  • *All of Secure BioMed’s work is confidential and proprietary to its client and not a candidate for publication.
Linda Braddon

7828 Hickory Flat Highway, Suite 120, Woodstock, GA 30188

(770) 837-2681

800-361-0945

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