Carla Wiese has over 22 years’ experience in the medical device industry in project management, research and development and regulatory disciplines. Prior to joining NAMSA in 2017, Carla held positions with Boston Scientific, Solace Therapeutics, and most recently the U.S. Food and Drug Administration (FDA). At the FDA, Ms. Wiese served as Lead Reviewer for cardiovascular devices before becoming the Program Director of the Early Feasibility Studies (EFS) Program where she oversaw development of new review strategies to help increase EFS in the United States.

CORE COMPETENCIES

• Leading teams and projects of various sizes; this includes providing direction and leadership of multidisciplinary teams comprised of statisticians, scientists, engineers, veterinarians and clinicians
• Assisting companies in development of strategic plans to obtain regulatory approval and achieve commercialization goals
• Supporting due diligence efforts for Clients and funders/investors
• Managing regulatory applications as FDA Lead Reviewer and creation of written FDA submissions, including: 510(k)s, pre-submissions, IDEs, IDE supplements, IDE annual reports, master files, PMAs, PMA supplements and PMA annual reports
• First-hand experience with multiple manufacturing processes and the development of quality control procedures and documentation as a Research and Development Engineer; this includes development of manufacturing, testing and inspection procedures

• Managing an Early Feasibility Study in Santiago, Chile and expertise in clinical risk mitigation strategies associated with early stage clinical trials 

• Developing new FDA review policies related to non-clinical test requirements and clinical trial strategies to support EFS in the U.S.; leading cross-cutting focus groups, including the seven (7) divisions of CDRH and OSEL while working with external organizations (NIH, MDIC) to support EFS implementation 

• Development experience in implantable, non-implantable, biodegradable, combination products and digital health (inclusive of Class I-III devices) 

• Managing projects for drug eluting, peripheral drug eluting balloons, introducer sheaths and dilators, angiographic and guide catheters, guidewires, vascular grafts, urinary balloon implants, biopsy devices, biodegradable urethral catheters, hemostatic clips, dialysis/apheresis catheters, wearable heart monitors, SaMD including clinical decision support tools, dialysis machines, extracorporeal blood modification systems, devices using virtual reality, combination thrombolytic devices, implanted brain-computer interfaces, novel fetal monitors, ex-vivo lung support system, intravascular ECG device, tinnitus devices and bone grafts 

• Deep understanding of food and drug law, Quality Systems regulations, design control, ISO 13485 and Corrective and Preventive Actions (CAPA)

RECENT PROJECTS 

• Plan and manage Breakthrough sprint interactions for a novel Class III device.
• Help client develop a high level test plan for an organ support system that meets FDA guidance recommendations
• Program lead for large U.S. FDA regulatory submission: management of various functions within internal and external partners to support biocompatibility, human factors, clinical, disinfection and software requirements 

• Assisted a start-up company in defining regulatory requirements, a test plan and determining an optimal global regulatory strategy for commercialization of a novel device 

• Aided an innovation incubator in defining a device intended use and description for a complex product with significant software usage; developed a test plan and drafted a pre-submission to verify the intended U.S. FDA regulatory pathway