Lisa C. Graney, RAC

Lisa C. Graney, RAC

Senior Consultant

Experience and Background

Ms. Graney joined Biologics Consulting in July 2017 and has 25 years’ experience in regulatory affairs and quality management systems for medical device companies, including orthopedics, ophthalmics, IVD’s, imaging anesthesiology and regenerative medicine (tissues and cells). Lisa and her teams have achieved numerous product approvals in both U.S. and international markets.

Prior to joining Biologics Consulting, Lisa was Vice President Global Regulatory & Clinical Affairs at LifeNet Health, where she became an SME in US and cell/ tissue international regulation and prepared regulatory strategies and analyses for products requiring BLA’s, 510(k)s, and RFDs as well as 361 HCT/Ps. Prior to LifeNet Health, Lisa was Worldwide Vice President Regulatory Affairs, at DePuy Synthes Inc., companies of Johnson & Johnson where she led an international team that achieved sixty+ 510(k) clearances, overhauling the EU Technical File program and files, and supported product submissions in 100+ countries. From 2005 through 2010, Lisa was the Global Manager, Regulatory Affairs at Bausch & Lomb, where she secured an original PMA for a new intraocular lens, managed several PMA products, submitted IRB’s and IDEs, achieved several 510(k) clearances and international product approvals, and re-registered all device products and 40+ B&L facilities and suppliers as foreign manufacturers in Japan. Previous to this, Lisa held managerial positions in Quality Assurance in Phillips Healthcare, Covidien, and a start up in vitro diagnostic manufacturer for which she achieved ISO 13485, CMDCAS, and CE marking for all products.

Lisa received a BS in Electrical Engineering from Rensselaer Polytechnic Institute, and holds the RAPS Regulatory Affairs Certification.

As a Senior Consultant for Medical Devices at Biologics Consulting, Lisa can use regulatory/quality expertise to assist clients in the following areas:

•Advising clients on the regulatory strategy and design control requirements for achieving medical device launches in the US, Canada, EU, and other international markets,
•Assisting clients preparing for transition to the EU Medical Device Regulations
•Preparing/assisting in medical device submissions in US (RFDs, Pre-IDEs, IRBs& IDEs, HDEs, 510(k)s PMAs) Canada (Class I-IV License applications, amendments), and EU Technical Files and International (STED) dossiers.
•Advising/provide training in best practices for Risk Management (ISO14971), Clinical Evaluation (for EU), Advertising and Promotion Review, Management of External Standards, among other Quality Management System processes needed for US regulation and ISO 13485 compliance.


Education

BS, Electrical Engineering, Rensselaer Polytechnic Institute (1992)

CERTIFICATION

2008-present Regulatory Affairs Certification (RAC)