At LDP Consulting, we specialize in helping manufacturers navigate the complex and ever-changing regulatory landscape of the medical device industry, ensuring that your products meet the highest standards of quality, safety, and efficacy.
Our team of highly skilled and experienced consultants has a deep understanding of the regulatory requirements and standards that govern the medical device industry, in Europe, the United States, and other territories. We work closely with our clients to develop customized strategies and solutions that address their unique challenges and goals, while always staying up-to-date with the latest developments in the industry.
Whether you are a startup developing a new medical device, or an established company seeking to expand your product portfolio, our consulting firm can provide the guidance and support you need to succeed. From product development to regulatory submission, from First in Human to pivotal and post-market clinical studies, we can help you navigate every step of the process.
At LDP Consulting, we are committed to delivering the highest level of service and expertise to our clients, and to helping them achieve their goals and objectives. If you are looking for a trusted partner to guide you through the complex world of medical device quality, clinical, and regulatory affairs, we invite you to contact us today to learn more about our services and how we can help you succeed.
Liat has more than 20 years of experience in regulatory affairs, clinical management, and quality assurance for medical devices. Prior to founding LDP and before that Duet Medical, two consultancy agencies, she served many years as the regulatory and clinical manager in start-up companies, mostly in the field of Class III cardiovascular devices, like BBalloon and ByPass Maakafim.
Her part in start-up companies allowed her to acquire a deep understanding of design and manufacturing constraints and limitations, risk management, and usability processes. She also has a vast experience in worldwide management of small and large-scale clinical trials, both for marketing approvals/ clearance and for post marketing surveillance purposes.
QA/RA Director and Team Leader
Neta has over 15 years of experience as QA/RA Manager and consultant in numerous medical device companies. Her experience includes implementation and maintenance of quality management systems in compliance with applicable regulatory requirements such as: ISO 13485, FDA QSR, MDSAP regulations and EU MDR and IVDR requirements. Neta conducts internal audits, supplier audits and supports companies in preparation and management of external audits, performed by regulatory authorities. In addition, Neta has a vast experience in supporting and managing manufacturing processes, design control activities and preparation and submissions of medical device technical documentation.
Neta holds a B.Sc. in Biomedical Engineering from Ben-Gurion University and has a Lead auditor certificate from the Standards Institution of Israel (SII).
Clinical Director and Team Leader
Yael has over 18 years of experience in clinical affairs management in numerous medical device companies. Her experience covers all aspects of clinical research, from the clinical science aspect of designing a study, to the actual clinical operations implementation and day to day oversight. Yael was involved in the preparation, execution, and management of clinical trials in Israel, Europe, and the USA, for various devices in different therapeutic areas, such as cardiovascular, valve diseases, heart failure, GI, orthopedics, ENT and general surgery. She has proven experience working in full compliance with the strict regulatory requirements of EU MDR, IVD and FDA CFR, as well as local requirements and QMS.
In addition, Yael conducts internal audits according to ISO 14155 and GCP requirements, participating in site and sponsor regulatory clinical audits, preparing and conducting summative HFE/usability studies.
Regulatory Director and Team Leader
Esther has over 5 years of experience in Regulatory Affairs for numerous medical device companies, representing all types of devices (from class I to class III combination devices). Her experience includes preparation of regulatory strategies; submissions and interactions with FDA (pre-submission, SIR, IDE, 510(k) notifications, etc.); preparation and submission of technical files and technical documentations to European Notified Bodies in compliance with the MDD, MDR, and IVDR; preparing and conducting summative HFE/usability studies; and assessment and documentation of Biological Evaluation, Clinical Evaluation, and Performance Evaluation.
Esther holds a M.Sc. in Human Pathophysiology and a Ph.D. in Molecular Biology. She is certified in Biological Safety by NAMSA.
Rotem Ben Chimol
Senior QA/RA and Clinical Project Manager
Rotem has over 9 years of experience as QA/RA and Clinical Manager and consultant in numerous medical device companies. Her QA/RA experience includes establishment and maintenance of quality management systems in compliance with applicable regulatory requirements such as: ISO 13485, FDA QSR, and EU MDR requirements; management and supporting design control related processes, including establishment of the product’s DHF, involvement in risk management activities and V&V testing; supporting the production team in development and maintenance of the product’s DMR and manufacturing processes validations; and preparation and supporting regulatory submissions in different territories. Her clinical experience includes management and coordination of multi-center studies, clinical study documents preparation, monitoring activities and study submissions to regulatory authorities.
In addition, Rotem conducts internal audits, supplier audits and supports companies in preparation and management of external audits, performed by regulatory authorities.
Rotem holds a M.Sc. in Biotechnology and B.Sc. in Mathematics from Bar-Ilan University.
Senior QA/RA Project Manager
Sharon has over 15 years of experience in QA/RA project management. Her experience includes the establishment, implementation and maintenance of QA/RA processes; writing procedures in various areas, including production and QA and establishing companies DMRs and DHRs for production control; supporting design and development activities and building design and development history files (DHF) including change control (ECO) process; ensuring compliance to regulatory standards (including MDR, IVDR, ISO 13485:2016, 21CFR820), project design requirements and product development quality plans; and prepare manufacturers for internal and external audits.
Sharon holds an M.Sc. in Life sciences, from Tel Aviv University.
Senior RA Consultant
Tamar has over 4 years of experience in management of multiple projects as RA Consultant providing regulatory support to a variety of medical device companies. Her experience includes strategic regulatory planning for the EU and US markets; FDA applications and Technical Documentation preparations and submissions; Clinical evaluations according to the Medical Device Regulation; Biological evaluations according to ISO 10993-1; Preparation for external audits, routine and continuous work with European (Notified Bodies, Authorized Representatives) and US (FDA) regulatory authorities; Conducting internal audits in compliance with applicable standards and regulations (including MDR, IVDR, ISO 13485, 21CFR820).
She also has extensive experience in scientific writing and broad laboratory experience as Head of Flow Cytometry Unit (FACS) in Hematology Laboratory, Carmel Medical Center, Haifa and National Blood Group Reference Laboratory (NBGRL), National Blood Services, MDA. Tamar holds an M.Med. Sc. and a Ph.D. in Neurosciences from the Faculty of Health Sciences, Ben-Gurion University of the Negev.
Senior Clinical Project Manager
Keren has over 14 years of experience in the field of global and local clinical trials operations and management for Pharma & Devices jointly. Her experience includes monitoring, high level oversight including milestones achievement and team delivery, reports review, quality controls and design, overseeing the development of clinical trial protocols and execution, data management for clinical trials at multiple sites, ensuring compliance with all regulatory and contractual requirements, for devices in various therapeutic areas, such as cardiology, ophthalmology, oncology, ENT, etc.. She is also experienced in SOP, monitoring plans and other study specific documents and supportive tracking tools issuing, sponsor internal audits and site audits according to ISO 14155 & GCP requirements as well as support for post-market activities and usability plans issuing and execution.
Keren holds a M.Sc in Molecular Microbiology and Biotechnology from Tel-Aviv University, Israel.
Júlia joined the LDP team in January 2022 and works as a QA/RA Consultant in various medical device companies, ensuring QMS in compliance with applicable regulatory requirements and supporting design control activities and related processes. Previously Júlia worked in Germany in QA/RA in Pharmaceutical Companies.
Júlia holds a PharmD from the Universität Hamburg, and a GCP certification.
Rachel joined the LDP team in May 2022 and works in the management of different projects as an RA consultant for a number of medical device companies ensuring compliance to regulatory standards. Smoking Cessation Counsellor at Quit Genius for 2 years, she was involved in a clinical trial for building an evidence base for the Quit Genius app and advising members in quitting via behavioral support and pharmacological intervention therapy.
Rachel holds an MPharm from University College London.
Caterina joined the LDP team in June 2022 and works as a RA consultant in various medical device companies, ensuring QMS compliance with applicable regulatory requirements such as ISO 13485, MDSAP, EU MDR 2017/745 and 21 CFR 820. Before joining us, Caterina worked several years as a Veterinary Surgeon, in both hospitals and clinics.
Caterina holds a D.V.M (Doctor of Veterinary Medicine) degree from the University of Parma (Italy).
Anna joined the LDP team in July 2022 as a QA/RA specialist, providing support and guidance for various medical device companies in QMS implementation and maintenance, meeting regulatory requirements (ISO 13485, EU MDR 2017745, 21 CFR 820, MDSAP) and Israeli market authorization process.
Anna holds a B.Sc. in Biology from Bar-Ilan University and has 12 years of experience at the Sheba Medical Center Cord Blood Bank, where she was responsible for the implementation, verification, and maintenance of regulatory standards and audit readiness for international and local audits. She was also in charge of executing and monitoring the process of shipping biological material for transplantation in Israel and abroad.
Einav joined the LDP team in June 2022 and works as a QA/RA consultant in various medical device companies, ensuring QMS compliance with applicable regulatory requirements such as ISO 13485, MDSAP, EU MDR 2017/745 and 21 CFR 820. Previously, Einav worked at an agritech startup company and is well familiar with the fields of sterile work and writing work procedures. Einav has also taken part in purchasing and finance activities.
Einav holds a B.Sc. in Biology from Tel-Aviv University.
Elinor Artsy Navon
Elinor has 20 years of research experience in both academic and industry settings in the United States and Israel, and clinical experience as a physician in both neurology and rehabilitation medicine. Her experience in academia and industry includes clinical trial design and protocol assessment, data collection and analysis, performance of literature reviews for clinical development and pharmacovigilance projects, as well as authorship of several publications and conference presentations.
She has previously worked at Harvard, the NIH/NIA, Brigham and Women’s Hospital, Rambam Medical Center, Philips Healthcare, and Clexio Biosciences, among others, and is proud to now be a member of LDP Consulting.
Elinor holds a B.A. from the University of San Francisco, an M.D. from the Technion Institute of Technology in Haifa, and a GCP certification.