APDC advisors from three different Atlanta companies comprise APDC’s Regulatory Core. These individuals assist innovators on a variety of different regulatory issues and serve as advisors to the APDC Executive Board and Committee. Their expertise covers a wide range of clinical and technical areas and they assist not only on regulatory pathways for APDC projects, but also in the area of Quality Systems and Design Controls.
Linda Braddon, PhD: Linda 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. In 1998 she founded Secure BioMed Evaluations (http://www.securebme.com) with the vision of assisting novel medical device products to the market by offering a level of scientific and engineering expertise that is not often available in-house for a start-up company. Under Dr. Braddon’s guidance, SBME offers comprehensive services including strategic FDA planning, mechanical test design for regulatory submissions, product development, manufacturing analysis, risk assessments, technical due diligence and numerous other technically focused activities that allow clients to expedite the pathway to commercialization.
Cathryn Cambria, MS: Cathryn Cambria has more than 25 years of experience in the healthcare industry field with a broad range of medical and dental devices, and in vitro diagnostic products encompassing chemical, electrical, and mechanical components, using plastics, metals, glass and a wide range of other materials. She has successfully run her own consulting company for over fifteen years. Ms. Cambria provides regulatory consulting, strategic planning, marketing submissions, manufacturing compliance, quality systems design and implementation, auditing, design and process validations, training, and risk management for clients. Areas of expertise include FDA regulations, ISO standards, QSIT, QSR, design controls, 510(k), IDE, and PMA submissions, process and product validation; and 483, warning letter, MDR, and recall resolution. Ms. Cambria holds an MS in Management from Polytechnic University, a BA in Biology / Chemistry from Mercy College and is an ASCP certified medical technologist. Ms. Cambria is a member of the American Society for Quality (ASQ) and is an ASQ certified quality auditor (CQA). She is also a member of the Regulatory Affairs Professional Society (RAPS) and is certified Regulatory Affairs Consultant (RAC).
Arthur Spalding, MBA: Arthur Spalding has over 25 years’ experience in pharmaceuticals and medical devices directing various functions including: reimbursement, clinical trial design and facility recruitment, distribution, business development, managed markets, market research, hospital sales, forecasting, and sales operations. Mr. Spalding held management and director level positions at various companies including Parke-Davis, Pfizer, Solvay, Peer-Point Medical Education, and Columbia Laboratories. In 2009, Mr. Spalding started TAMM Net, Inc., (http://www.tammnet.com) a consultancy servicing biomedical manufacturers. TAMM Net has helped manufacturers: conduct clinical trials using federal resources; gain reimbursement; gain marketing approvals/clearances; and sell to federal purchasers. Mr. Spalding holds a B.S. in Chemistry from Union College, Schenectady, NY and an MBA in Health Administration from Temple University in Philadelphia.