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, Ph.D. 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.
Arthur Spalding, MBA Arthur Spalding has over 25 years’ experience in life science manufacturing directing various functions including: reimbursement, clinical trial design and facility recruitment, distribution, market research, hospital sales, and sales operations. In 2009, Art started TAMM Net, Inc., (http://www.tammnet.com) a consultancy serving biomedical manufacturers. TAMM Net helps manufacturers navigate the federal government, capturing opportunities and overcoming obstacles to commercialization. We facilitate conducting clinical trials using federal resources; understanding and gaining reimbursement and marketing approvals/clearances; and selling to federal purchasers. Our reimbursement and regulatory experts have expansive resumes and relationships with key stakeholders. We support the growing medical device cluster centered around Georgia Tech by lecturing, mentoring, and advising numerous inventors.
Cathryn Cambria, M.S. 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. 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. Cambria holds an M.S. in Management from Polytechnic University, a BA in Biology / Chemistry from Mercy College and is an ASCP certified medical technologist. 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).
Susan Alpert, Ph.D., M.D., Principal, SFA Regulatory, LLC: This consulting firm is focused on working with start-up companies, mainly in the medical technology space, to assist them in understanding the development needs and data requirements for placing their products into the US heath care market. The work specifically addresses the testing requirements and documentation of results required to support both product development and the clinical testing required by the US regulatory agency. Interaction with the FDA early in the process and throughout product development to receive appropriate feedback on development plans and execution is a focus of this work as well.
Greenlight Guru is a quality management platform designed specifically for medical device companies.
The platform helps companies get safer products to market faster, simplifies FDA and ISO regulatory compliance and provides a single source of truth by connecting the management of all quality processes like CAPAs, risk, audits, document control, training, design control, and more.
Device makers across the globe are replacing their outdated paper-based and general purpose legacy quality systems with Greenlight Guru to push beyond baseline compliance achieving True Quality. For more information or to request a demo, visit http://www.greenlight.guru.