Anna Libman Email & Phone Number

New Brunswick, Nj, Us

Redwood City, California, Us

San Jose, Ca, Us

- Works with company executive leadership to define efficient regulatory path to market and executes on the plan with the client's cross-functional team- Leads regulatory submissions for a wide variety of devices and combination products; develops 510(k)s, IDEs, de novos, Technical Files and other international submissions for global regulatory approvals- Serves as client company's regulatory head in interface with FDA: Connects with FDA reviewers and leadership to promote clearances of client’s technology and prepares the company for meetings with FDA, including strategy for reaching meeting goals and presentation content- Evaluates the adequacy of device testing (e.g., verification and validation, software, electrical safety & EMC, and biocompatibility testing) and other supportive documentation (e.g., labeling, Risk Management, and Software Lifecycle Management) for effective submission substantiation- Support implementation of QMS and serves as company's regulatory rep - Manages and trains the firm’s associates - Provides regulatory support for investor and acquirer due diligence activities- Establishes new client relationships and fosters effective long-term relationships - Develops project management tools to provide efficient project execution

San Jose, Ca, Us

- Develops regulatory strategies for U.S. and EU commercialization of medical devices and digital health products- Manages regulatory submissions (meetings, clinical studies, and premarket) for a wide spectrum of product, including mobile health, patient monitoring, diagnostic, medical software, cardiovascular, neurological, and ophthalmic devices - Provides guidance to product development teams to meet regulatory objectives - Represents companies in interactions with FDA and Notified Bodies- Designs and manages device human factors and usability testing - Assists startups in managing product development activities- Manages acquisition of new accounts and ongoing relationships with existing clients- Helps perspective clients identify regulatory road maps to commercialization- Establishes strategic partnerships for the firm

San Jose, Ca, Us

- Advise medical device/ digital health startups and corporations on regulatory strategy towards commercialization- Prepare regulatory submissions: --- U.S. submissions: 510(k), pre-IDE, and IDE submissions and respective FDA communication --- EU submissions: Technical Files, Design Dossiers, Clinical Evaluation Reports, and MHRA clinical trials applications - Evaluate adequacy of device testing (e.g., verification and validation, electrical safety and EMC, biocompatibility, and usability testing) and documentation (e.g., software, risk management, and labeling) for compliance and effective regulatory submission substantiation- Support clients in development of software requirements and design documentation as well as risk management, traceability, and testing- Manage and develop device testing- Contribute to clinical trial design- Maintain current knowledge of FDA regulations, guidances, and standards

San Jose, Ca, Us

- Drafted regulatory submissions and regulatory strategies for U.S. and EU commercialization for a wide array of medical devices.- Conducted literature reviews

Los Angeles, Ca, Us

MBA program with focus on entrepreneurship and finance. Experienced immersion in startups formation/operation/fundraising in Israel and Berlin.

San Jose, California, Us

- Initiated and maintained relationships with healthcare providers- Contributed to revenue growth in assigned territories

•Participated in advanced medical treatment program. Assisted patients and physicians in the clinic

•Development of evaluation methodology for “Artemis Top 50”competition of startup water technology companies•Worked with leading experts in water technology to establish effective evaluation criteria•Received and applied feedback from industry experts, reporters, and participating companies

•Analyzed patients pre-Lasik and post-Lasik operational information•Developed a database of patients’ medical history, data analysis and computation charts•Co-authored the research paper, pending publication: "Symptomatic post-LASIK binocular vision disorders: Prevalence and pre-operative risk factors"

Mba, Finance And Entrepreneurship

Master Of Business Administration (M.B.A.), Entrepreneurship Study Abroad

B.S, Biochemistry And Molecular Biology