Meredith Andress serves as a Recall Coordinator for medical device recalls under the Compliance Branch, OMDRHO Division 2. Currently she is one of 9 recall coordinators for the medical device program and responsibilities include reviewing and recommending new recalls for classification by CDRH, monitoring ongoing recalls within Division 2, terminating those recalls, and advising follow up as needed. She became a Recall Coordinator in March 2015 and has been a frequent speaker of recall-related topics with industry for Medical Devices, and Food in the past. Meredith has been with the FDA for 11 years and prior to her current position as Recall Coordinator, served as a Consumer Safety Officer, performing inspections in multiple commodity areas. She received a master’s degree in Public Health, with a specialization in Veterinary Public Health, from The Ohio State University.
Blake has been with the Food and Drug Administration since 1989. He was an Investigator for 12 years which included conducting foreign inspections. He accepted a Supervisory Investigator position in 2001. Following his participation in the FDA Leadership Program in 2005 and 2006 he became an Operations Director and worked directly with the Associate Commissioner for Regulatory Affairs and other agency leaders involved in ORA strategic planning, budgeting, and organizational initiatives. He became the Director of Compliance for Los Angeles District in 2009 and assumed the Director of Compliance position in Florida District in 2014. He is currently the Program Division Director for Division 2 Central within the Office of Medical Device and Radiological Health Operations. As the Director of Division 2 Central, he leads all device inspectional and compliance activities that formerly resided in the seven District Offices of ATL-DO, CHI-DO, FLA-DO, KAN-DO, MIN-DO, NOL-DO, and SJN-DO. He graduated from Harding University with a Bachelor’s degree in Biology, Arkansas State University with a Master’s of Science degree in Biology, and completed a Senior Executive Development program at George Washington University.
Frances Cohen is President of Promenade Software Inc., a leading software services firm specializing in medical device and safety-critical system software. Frances has more than 20 years of experience leading software teams for medical device software. Starting with heart defibrillators for Cardiac Science and following with Source Scientific LLC and BIT Analytical Instruments Inc., Frances has overseen dozens of projects through development and the FDA, including IDEs, 510(k)s, and PMAs.
Frances has a B.S. in computer engineering from the Technion, Israel Institute of Technology.
Jay Crowley is currently Vice President, Medical Device Solutions and Services, at USDM Life Sciences. Prior to joining the firm in January 2014, Crowley was Senior Advisor for Patient Safety, in FDA’s Center for Devices and Radiological Health. He held a variety of positions over his nearly 27 years at FDA. Jay had primary responsibility for the development and implementation of FDA’s Unique Device Identification System and the development of the GHTF and IMDRF UDI guidance documents.
Seppe de Gelas
- Located / based near Brussels in Belgium (Europe)
- Peptide chemist by education (Free University of Brussels)
- Started my career +25years ago in clinical research (Bristol-Myers Squibb), evolved into Quality Assurance and Regulatory Affairs of several pharmaceutical production units (Baxter International, Belgian-based HQ of UCB & Lonza)
- Between 2010 & 2015 owned my own laboratory doing QC testing & batch release for the European market.
- Latest responsibilities included auditing a myriad of pharmaceutical and medical device suppliers and subcontractors and a QA & RA director position at a medical device ISO13485 certified start-up company, developing a sub-cutaneous continuous glucose sensor.
- Currently holding a position as director QA & regulatory affairs at Hyloris Pharmaceuticals, a virtual pharmaceutical company focusing on products using FDA’s 505b2 regulatory approval pathway.
- Faculty member of the UGA since 2017 teaching various classes including European regulatory affairs and Process control & Process validation.
Philippe Etter is the Founding partner of Medidee – a leading Swiss consulting firm specializing in Regulatory, Quality and Clinical affairs services within the medical device industry. He has served in the MedTech compliance and innovation sector for 27 years and is currently driving the USA operations in New Jersey. His background includes experience as a hardware and software development engineer in the field of biological components separation for a USA based company. Medidee serves on ten sites throughout Europe and the USA, located around the areas of active MedTech innovation. One of the key missions is to support American companies on their way to the EU markets with the current transitions of the EU regulations. Philippe’s expertise includes strategic and tactical consulting on regulatory and clinical pathways for critical products such as active medical devices, AIMD, extra corporal circulation, implants and IVD. To better serve the community, Philippe leads in three European Universities a set of continuous training programs preparing leaders for current and upcoming MedTech challenges. Philippe holds an MSc in micro technology from Swiss Institute of Technology and a level III European certificate in medical devices sterilization.
Brittani Franklin, Consumer Safety Officer
Office of Medical Devices Radiological Health Operations (OMDRHO)- Division II
Office of Regulatory Affairs
CSO Franklin joined FDA in 2014 working in the Chicago District Office as an Import Investigator. She inspected and reviewed the compliance of all FDA regulated products that were being imported from around the globe through the international port of entry located at the Chicago International Mail Facility. Later, she transitioned to solely conducting inspections related to medical devices and combination products. Due to her expertise in the field, she became a member of the dedicated foreign cadre conducting complex medical device investigations and inspections internationally, training new investigators, and speaking on panels to provide educational resources to industry to help fulfill the Agency’s mission. Ms. Franklin continues to be an advocate for the health of all Americans, but specifically minorities.
Alireza has been with TUV SUD since January 2020 as a Product Assessment Expert. In this role, is involved with Technical Document Assessments and Audits for Active Implantable Medical Devices. He graduated with his bachelor’s degree in Biomedical Engineering from Tehran Polytechnic University in Iran, and his master’s degree in Bioengineering from University of Denver. Prior to working at TUV SUD, he was employed on the industry side, as a Systems Engineer for implantable neurostimulator medical devices.
In addition to his instructional role at The University of Georgia Institute for International Biomedical Regulatory Sciences, Al is the Vice President of Quality Assurance at Axogen Incorporated. Al has over 25 years of Quality and Regulatory experience, including serving in leadership roles at a variety of pharmaceutical and medical device companies, including Glaxo (now GSk), J&J, and CR Bard; as well as successful start-ups CorMatrix, Alimera Sciences, and VERO Biotech. His regulatory experience includes numerous NDA and 510(k) submissions, and he is passionate regarding achieving and sustaining consistent regulatory compliance. He has successfully implemented multi-site global quality management systems that meet FDA and international compliance requirements for pharmaceuticals, medical devices, and combination products, and is passionate about developing Quality Management Systems that achieve global regulatory compliance using a data-driven approach. Al is also a mentor who enjoys helping talented people capitalize on their strengths so they can best contribute to both their personal and company success.
Jenny provides expert technical services to regulatory strategies in a global market context. With over five years of research experience on molecular biology, microbiology, immunology and biomedical engineering in both academic and clinical setting.
Jenny has achieved significant regulatory approvals for medical devices and in vitro diagnostics in multiple markets, specifically Asian Pacific countries. She also has first-hand experience in project management throughout product development phases and registration cycle, e.g., provision of regulatory strategy, development of technical files, coordination of lab testing, regulatory support for clinical trials, on-site consultation with regulators, and post market compliance.
Jenny has a Master of Professional Engineering (Biomedical), Master of Science (Microbiology) and Bachelor of Science (Life Science) degree.
Toby Lowe is Associate Director for Regulatory Programs in the Office of In Vitro Diagnostics (OHT7 – Office of Health Technology 7) in the Office of Product Evaluation and Quality (OPEQ) at the U.S. Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH). As Associate Director, she guides development, implementation, and communication of policies to address regulatory issues for a wide range of in vitro diagnostic devices (IVDs), including issues related to laboratory developed tests (LDTs), pharmacogenomics, companion diagnostics, the emergency response for COVID-19 and monkeypox, and others. As part of OHT7’s leadership team, she develops and coordinates feedback on queries from the press and other stakeholders and on legislative issues, as well as supporting Center leadership in both internal and external work on development and advancement of policy on IVDs. Ms. Lowe also advises Office and Center leadership and staff on a variety of regulatory policy issues and manages communications efforts for the Office. Ms. Lowe is a biomedical engineer and has been at the FDA since 2008.
Karen Masley-Joseph has worked in FDA’s Office of Regulatory Affairs for over 20 years. She started as an investigator in the Chicago District Office and later became a medical device specialist. Ms. Masley-Joseph has held positions as a compliance officer, a Regional Quality System Manger, Director of ORA’s QMS, and a case review specialist in the Division of Enforcement. In 2019, she returned to her medical device roots as Senior Advisor in the Office of Medical Device and Radiological Health Operations (OMDRHO). In this role, Karen serves as OMDRHO’s policy and strategic planning expert and is OMDRHO’s lead for implementation activities related to FDA’s proposed 820 transition. Karen holds both a BS in Chemical Engineering and an MBA from Northwestern University. She is an ASQ Certified Manager of Quality/Organizational Excellence, Certified Medical Device Auditor, and Six Sigma Green Belt.
Andy Meadows is a highly experienced software engineer and architect, technology author, and digital healthcare entrepreneur with more than 30 years of experience in the field, having developed and implemented successful software and IoT solutions for clients across a wide range of industries, from digital entertainment and Internet security to financial services and healthcare. As owner and operator of Meadows Design, LLC, a boutique software design firm, he specializes in the design, development, and deployment of software for use in medical device systems to provide more accurate diagnoses and better outcomes. Some of his most distinguished projects include nfant Labs’ Thrive Feeding Solution; TendoNova’s FDA-approved Ocelot fragmentation and debridement treatment solution; Uh Oh Labs’ fast and affordable PCR Covid testing solution for labs and clinics; and Ethos Medical’s Iris, a real-time ultrasound guidance system for spinal access. Meadows holds a Bachelor of Science degree in Computer Science from the University of Georgia’s Franklin College of Arts and Sciences.
Melissa O’Connor, M.S., FRAPS, RAC, CTBS has more than 20 years of experience in medical device, combination product, and human tissue new product development research, engineering, and commercialization. She has experience in Quality System design, implementation, maintenance, and compliance. Melissa has held Quality leadership positions serving as the Management Representative, Head of Quality and official FDA correspondent for prescription eye-glass lens manufacturer QSpex Technologies, Inc., and Chemence Medical Products, Inc, a global manufacturer of adhesive based Class II medical devices for would closure. During an 11-year tenure with Kimberly-Clark Health Care, Melissa held positions in Regulatory Affairs, Product Development, and Process Engineering. In addition to Quality Systems expertise, Melissa is skilled at developing comprehensive regulatory strategies to support new product development including pre-market approval requirements for U.S. and E.U. She is a member of the Regulatory Affairs Professional Society (RAPS) and holds an active RAC certification. Melissa holds a B.S. degree in Biological Sciences from the University of Georgia and an MS Degree from the University of Georgia School of Pharmacy in Biomedical and Pharmaceutical Regulatory Affairs.
Melissa is a founding member and currently serves as the Chief Quality and Regulatory Officer for StimLabs, LLC based in Roswell, Georgia. In her current role, Melissa is responsible for all aspects of Quality and Regulatory Affairs for StimLabs including Quality Assurance, Quality Control, Quality Engineering, Quality Management Systems, Donor Services, as well as global regulatory compliance and submissions.
Melissa is a member of the American Association of Tissue Banks, where she currently serves as the Program Committee Chair, is a member of RAPS and a 2022 RAPS Fellow.
As the VP of Global Regulatory Strategy & Policy at Medtronic, Yarmela Pavlovic helps to guide the development of efficient regulatory strategies for the company’s most innovative products, such as AI-enabled technology and connected devices. Additionally, Yarmela helps to guide Medtronic’s external global regulatory policy development work across a range of domains.
Before joining Medtronic, Yarmela was a regulatory consultant, focused primarily on FDA premarket regulatory strategies. Yarmela has extensive experience in product development and product marketing authorization submissions, as well as a variety of other device-related regulatory issues.
Yarmela has particular experience in the area of regulation of digital and AI-enabled technology, as well as medical software and applications. Yarmela has authored numerous articles and been an invited speaker on topics ranging from digital health regulatory strategies to machine learning policy development, among others.
Salvatore (Sal) Randazzo joined the FDA, Office of Regulatory Affairs (ORA), Florida District Office in 2002, as part of a new hire initiative following September 11, 2001. As an Investigator in Florida District, Sal specialized in the medical device and drug program areas where he conducted complex inspections involving high-risk products and processes. In 2009, he joined the Florida District Compliance Branch as a Compliance Officer processing cases involving medical device and drug manufacturers that were found non-compliant with Agency-enforced laws and regulations. In 2017, following ORA’s program alignment, he continued his work as a Compliance Officer in the Office of Medical Devices and Radiological Health Operations, Division 2 – Central, Compliance Branch. He also serves as Technical Expert for FDA’s AAMI Standards Workgroup 1, Industrial EO Sterilization. Sal is a recipient of the FDA Outstanding Service Award.
Christopher Rolfes earned his PhD from the University of Minnesota. He has worked in research in development in for more than 15 years, working at various settings including universities (Minnesota and Georgia Tech), a large corporation, and two small startups (including one of his own). He has spent the last six years at GCMI, a medical device testing and development CRO. During his career, he has contributed toward testing and development of pacemakers, ablation systems, wearables, as well as surgical tools, thrombectomy systems, and more.
Linda Ricci began her career developing artificial intelligence solutions in the defense industry before moving to the medical device industry as a software engineer. She helped to develop several diagnostic cardiology devices and has participated in all phases of product life cycle development. Ms. Ricci moved to the FDA in 2005 and has had several roles including Scientific Reviewer and Branch Chief within the Division of Cardiovascular Devices and Associate Director for Digital Health within the Office of Device Evaluation. Currently Ms. Ricci is the Director for the Division of All Hazard Response, Science and Strategic Partnerships (DARSS). This role involves leading teams focused on Medical Device Cybersecurity, Standards and Conformity Assessment, Health of Women, Pediatric and Special Populations, Patient Science and Engagement, Partnerships and Regulatory Science, and Emergency Response including device shortages due to COVID. She has degrees in Electrical Engineering, Medical Engineering, and Public Health.
Ouided Rouabhi currently serves as the Assistant Director for Policy and Operations Team 1 within the Office of Clinical Evidence and Analysis in FDA’s Center for Devices and Radiologic Health (CDRH). Her current role includes providing regulatory guidance to internal and external stakeholders regarding the interpretation and application of policies and procedures related to the IDE, Breakthrough Devices, Safer Technologies, and Expanded Access Programs, among others. Prior to this role, Ouided served as a policy analyst within this team, and prior to that, as a premarket reviewer in the Office of Cardiovascular Devices where she reviewed cardiac electrophysiology devices. Ouided also previously served as a biomedical engineer and reviewer in FDA’s Center for Tobacco Products, where she specialized in electronic cigarette research and policy. Ouided received her Master’s and Bachelor’s degrees in Biomedical Engineering from The University of Iowa.
Cassie Scherer is the Director of Digital Health Policy and Regulatory Strategy at Medtronic. In her position, she leads global policy work relating to digital health technology, including AI/ML-enabled products, as well as US FDA regulatory policy work. Cassie is one of the GMTA industry representatives for the IMDRF SaMD Working Group and also co-leads with FDA the Digital Health Initiative at the Medical Device Innovation Consortium (MDIC) that focuses on collaboratively and strategically advancing regulatory science for digital health technologies.
Before Medtronic, Cassie was Special Counsel at a law firm providing strategic regulatory counsel to medical device and digital health companies. Cassie’s practice focused on premarket review, compliance with FDA’s pre- and post-market requirements relating to medical devices and FDA jurisdictional issues. Cassie also served at U.S. FDA where she was Associate Chief Counsel in FDA’s Office of Chief Counsel and Director of Strategy and Regulatory Operations in CDRH’s Office of Center Director. While at FDA, Cassie advised and consulted on a broad range of matters relating to emerging medical device issues, responding to Congressional inquiries, implementing legislation relating to medical devices, reviewing premarket appeals of regulatory decisions made by CDRH, and developing regulations and key FDA guidance documents.
Alex Smith is a software engineer at the law firm of Hogan Lovells LLP in Washington DC.
As a former process and software engineer at GlaxoSmithKline and Human Genome Sciences, Alex’s primary practice involves assisting companies with medical device and pharmaceutical submissions that involve software such as AI/ML submissions, Data Integrity and 21 CFR Part 11 concerns. During his time at Hogan, Alex has provided software architecture and lifecycle advice on variety of devices such as AI/ML radiological imaging, Brain Interface Devices, Robotic Surgery Devices, 3D adaptive manufacturing, infusion pumps, and individualized vaccines involving AI.
Kimberly A. Trautman is an experienced Medical Devices, InVitro Diagnostics, and Combination Product Expert with over 30 years of experience. She worked at the US Food and Drug Administration (FDA) for 24 years and continues to work with Regulatory Agencies around the globe. Industry experience as well as regulatory agency experience. Demonstrated history of working collaboratively with industry, regulators and patient groups for the betterment of public health. Executes several medical device regulatory services and developed a formal Education/Training business. Established an Authorized Medical Device Single Audit Program (MDSAP) Auditing Organization and a new Notified Body for EU IVDR/MDR Designation.
Expert in global medical device regulations, wrote and harmonized the current US FDA Quality System Regulation and was on the international authoring group of ISO 13485 since inception. Conceived and developed the Medical Device Single Audit Program and its consortium of five Global Regulators. Twenty-year veteran of the Global Harmonization Tasks Force (GHTF) and foundational member of the International Medical Device Regulators Forum (IMDRF). Recognized International Medical Device expert with a Master’s Degree in Biomedical Engineering.
Linda Westfall is the president of The Westfall Team, which provides software engineering, quality, and project management training and consulting services. Linda has more than 40 years of experience in the software industry. Linda is the author of The Certified Software Quality Engineer Handbook. Linda is a past chair of the ASQ Software Division, a contributor to the PMI PMBOK, an ASQ Fellow, and ASQ CSQE, CMQ/OE, CQA, CBA, a PMI PMP, and has other certifications. Linda’s hobbies include building fireworks and she is a Pyrotechnics Guild International Grand Master.
“Dr. Smriti Zaneveld is a scientist and entrepreneur with a PhD in Molecular and Human Genetics from Baylor College of Medicine. In her academic career, Dr. Zaneveld pioneered genetic engineering technologies in developing therapeutics for inherited neurodegenerative diseases and has published dozens of scientific papers and presented her work internationally. However, when she was a Ph.D. student, she started 3D printing as a hobby. Working nights and weekends, together with Dr. Jacques Zaneveld, she developed a method to 3D print exact copies of patients from MRI and CT scan data in extremely realistic materials. This patented technology has changed the standard of care for surgery by allowing doctors to rehearse surgeries ahead of time. Once she graduated, she co-founded Lazarus 3D to help doctors operate with confidence. Under her leadership, in 2021 Lazarus 3D received its first FDA clearance for Pre-Sure, a patient specific surgical rehearsal platform that enables surgeons to visualize digital 3D data in XR and perform hands-on surgical rehearsals on physical replicas of patients organs, made in soft-tissue mimicking materials. Pre-Sure has already been adapted by top hospitals such as the Cleveland Clinic, the Texas Children’s, Miami Health Systems and MD Anderson. Lazarus 3D is paving the path for the next era of medicine through innovative technologies focused on improving patient safety and medical outcomes.”
Qianqian is the Director of International Regulatory Affairs at Immucor, Inc. In this role, she is responsible for the management of international regulatory requirements, including product registration, compliance to importation regulations and post-market vigilance. She supports cross-functional teams within Immucor for product commercialization planning and market strategies.
Qianqian has more than 10 years of direct regulatory experience with Class III medical devices, IVDs and drug products with China’s National Medical Products Administration (NMPA). Qianqian participated in the development of 7 technical evaluation guidelines for China’s Center for Medical Device Evaluation (CMDE) and several national standards and reference materials with China’s National Institute for Food and Drug Control (NIFDC).
Qianqian was a key speaker at The RAPS Convergence 2017 and 2022, covering China IVD registration strategies. She is also a frequent speaker at the RAPS and AdvaMed workshops on China registration best practices.
Qianqian holds a Master of Business Administration (MBA), a Master of Laws (LL. M.) and an RA graduate certificate from The University of Georgia. Qianqian received RAC Global certification in 2016. Prior to her career in the US, Qianqian practiced Law and International Trade in China and the UAE.