Irit Michaeli's Contact Details

Irit Michaeli's Company Details

MedicSense

Petah Tikva, Center District, Israel • 11 Employees
Medical Devices

MedicSense Ltd., one of the leading clinical & regulatory affairs companies in Israel, was established to assist medical devices manufacturers to contend with clinical, regulatory and QMS requirements. MedicSense has over 20 years of experience providing services such as design of pre-clinical and clinical trials, CRO activities including monitoring data management and data analysis, technical and regulatory affairs from the early stages of the product to the final stages of certification (FDA, CE, and more), establishment of quality systems and a comprehensive range of complementary services such as European Authorized Representation, U.S. Agent, Strategic Market Review, Reimbursement, Quarterly Standards Review and more.MedicSense has a Boston-based subsidiary to enable direct liaison with the FDA and a European office in Waterloo Belgium for our European-based clients. MedicSense is comprised of a competent multidisciplinary team to assure that every aspect of its work is professionally addressed.Our strengths are based on our extensive R&D, engineering and techno-regulatory background and experience with a wide range of medical device technologies. We know how to get products past the regulatory hurdles by providing pragmatic solutions. We understand the needs of the vibrant high tech medical device industry and the dynamic regulatory environment.MedicSense acts as an Israeli Registration Holder (IRH) for foreign companies that export their devices to Israel.MedicSense is the exclusive representative of NAMSA Inc. and the British Standard Institute (BSI) Academy in Israel.