Our Multidisciplinary Panel of Experts
Our broad expertise will support all aspects of regulatory compliance throughout your medical product life cycle
After an 11-year career in the Pharmaceutical industry as regulatory affairs manager and responsible pharmacist, Iris focuses since 2007 in assisting medical device companies in setting up, implementing and subsequently obtaining Quality Management System certification compliant with the international standard ISO 13485:2016, the EC Regulations, Canadian Medical Device Regulations and the FDA Quality System Regulations.
Iris Leinwand, MBA
Harry has a Master's degree in Chemical Engineering from the Polytechnical Institute, Bucharest, Romania, is a Certified Quality Engineer by the American Society for Quality and graduated the "Phil Crosby" Quality College, Winter Park, FL. USA.Between 1980 – 2000 served as Director of Quality Assurance and Regulatory Affairs at Teva Medical Ltd. (formerly Travenol/Baxter Laboratories Ltd).As of 2000 Harry is the founder and Managing Director of “R&Q Consulting Ltd.”, a consulting company which provides services in Quality Systems and Regulatory Affairs for companies in the medical device industry. The extensive experience accumulated in sterilization and aseptic processing enables Harry to serve as Sterilization Expert for the Notified Body DEKRA Certification BV in The Netherlands and sterilization consultant for many companies.
Harry Leinwand, M.Sc., CQE.
Abraham Nyska, DVM, Diplomate, Dipl. ECVP
Fellow IATP, Expert in Toxicologic Pathology
Visiting Full Professor of Pathology, Tel Aviv University For 40 years – experience in pre-clinical risk assessment of chemicals, drugs, medical devices and stem cells. For 18 years – served as Expert in Toxicologic Pathology at the American National Toxicology Program (NTP) of the National Institute of Health (NIH). From 2005 – serves as a consultant in Toxicologic Pathology - Pharmaceutical, CRO’s, and Federal institutes - In Israel, Europe, Japan, India, USA. Associate Editor of “Toxicologic Pathology”; Co-author of more than 440 peer reviewed publications and/or chapters in books. Member of international expert committees for harmonisation of terminologies in toxicologic pathology (IN-HAND initiative). Deeply involved in the introduction and application of newly developed, self-containing imaging systems, which provide an efficient and cost-effective means to rapidly obtain in- vivo and ex-vivo magnetic resonance imaging images to improve how we perform toxicology and toxicologic pathology. Deeply involved in the application of state-of the art digital telepathology solutions for real time peer review and pathology working group applications in the field of toxicologic pathology.
From 1985 up to date Dr. Koren-Morag has been a lecturer for statistics and research methods in the department of statistics, Exact Science, and the department of Epidemiology and Preventive Medicine, Sackler Faculty of Medicine, in Tel-Aviv University. She was also a Data Analyst and Statistics Consultant in the "Statistics Laboratory" in Exact Science department, and Statistical and Epidemiology consultant for MD, Ph.D. and M.Sc. students in faculty of Medicine, at Tel-Aviv University. The consultant involves research methods, sample size calculation and statistics analysis methods for MD's, MSc's and PhD's thesis. Dr. Koren-Morag was a member in professional committees: the Committee for the National Council for sodium consumption survey; the Committee for the National Council for Prevention of stroke and the Committee that organized the National Survey of Acute Cerebrovascular Disease in Israel for ministry of health.
Nira Koren-Morag, Ph.D.
Biostatistics & Data Analysis Expert
Michal Roll , Ph.D.
Dr. Michal (Micki) Roll is an experienced healthcare and business development professional, dedicated to advancing translational research. Micki was the Deputy Director General of R&D at Tel Aviv Medical Center(TASMC)(2000-2018) and first CEO of AvivMedTech(tech transfer R&D co. of TASMC). She had previously served as the Director of the Research Department at Hadassah Medical Organization (HMO).She holds an MBA, PhD in Medical Sciences (Pharmacology) with a Post Doctorate in Neurobiology and training in IP protection. Micki has vast experience in clinical trials, infrastructure development and international accreditation, as well as establishing and advancing translational R&D, with particular emphasis on emerging technologies, such as gene therapy and immunotherapy, for the leading Israeli hospitals, Tel Aviv Medical Center, and Hadassah Medical Organization.
Healthcare & Business development expert
Nextar Chempharma Solutions Ltd. Is an outsourcing company providing fully integrated contract drug development and manufacturing services. By combining formulation and analytical testing with GMP manufacturing and packing for clinical trials, Nextar offers a seamless support package.
We brought together industry's leading scientists and highly-reputable R&D and production teams to support our customers with strong expertise in cutting edge technologies. Our professional and experienced team is focused on two major principles: Quality of work and Cost effectiveness.
Bioforum is a data focused CRO with over 10 years of clinical research experience.
We offer a wide range of clinical data services to include medical writing, data management, clinical programming, biostatistics and pharmacovigilance. Our goal is to consistently improve and innovate data processes to support our clients in the utilisation of their clinical data and guarantee its integrity and accuracy for the most efficient data submissions. With a multi-disciplinary team of experts, we provide a unique and high-quality solutions for efficient collection, standardisation and reporting of clinical research data. Our professional teams enable clients to manage and analyse their data through integrated visualisation and analytical capabilities. We are multinational company with offices in Israel, the US, Australia and South Africa.
Amir Inbar, MBA
As an expert reimbursement consultant Amir works with organizations ranging from incubator start-ups to publicly traded companies, assisting them with the development of their reimbursement strategies in the US and Europe, their drug/device related value stories and economic models.
Prior to Mediclever, Amir worked for various software, telecom and medical device companies (Jungo Software Technologies, Iamba Networks and Super Dimensions), leading marketing, business development and reimbursement activities. Amir runs the reimbursement course at the Graduate Program of the School of Business of the College of Management for MBA students with specialization in biomedical management. Amir holds a bachelor's degree in Law and Economics from the Haifa University and an MBA from the Tel-Aviv University.
CEO, MediClever Reimbursement Consultants
Iman Khorshid holds a M.Sc. in quality assurance and reliability from the Technion, and a MBA from Haifa University, and LLB from academic center Shaare Mishpat.After a long industrial experience as a VP QA& RA of more than twenty three years and multidiscipline academic knowledge, she founded QRS – Quality & Regulatory services Ltd.Leading medical device and IVD companies to become global leaders in their field, participating in building global marketing strategies and reducing time to market.
Iman Korshid, MSc., MBA, LL
QRS Global QA, RA, Validation Expert