Our team comprises professionals from the medical device field - the team is proficient, focused, and includes first-class medical regulatory experts in: medical devices registrations, import of medical equipment, ISO 9001 audit preparation, dossier preparation – Israeli AMAR Registration, CE, ISO13485 and 9001,FDA - all classes, business development in the medical device field, etc.
A team of bio - engineers, professionals with degrees in life sciences with vast backgrounds in the medical devices field, and lawyers.
The company’s founders and executives have 15 year’s experience in the medical device field, expertise in registration of a wide range of medical devices, and are very familiar with many companies both in Israel and worldwide (focus on Germany).
They also have extensive experience in business development of companies, establishment of a global network of distributors, and professional consultation focused on the medical field, management of international trade - all aspects of import and export, including handling international contracts.
The Owners:
Liat Nadel
Liat holds a Master of Laws degree from Bar Ilan University, she is an RA Specialist - has a rich background in the medical devices field, she managed registration departments in various companies - with 15 years experience - she has a deep knowledge of all requirements, processes, Israeli & international regulatory approvals and required requests and regulations.
She also has vast experience in foreign relations (she speaks German, English, French and Hebrew), exhibition management, and logistics - import export management.
Shuky Nadel
Shuky served for many years as a medical equipment sales manager in Israel and Europe, and worked in operating theaters in many hospitals in Israel and Europe . He has a vast knowledge of medical procedures.
He also served for many years as a European sales manager in medical devices companies, and contributed greatly to fostering extensive relationships overseas and establishing a network of distributors for these companies. Shuky Nadel is an extremely experienced medical device registration specialist, and he is very familiar with the Israeli health institutions and their processes, on one hand, and he has a vast technical professional knowledge in medical devices - instruments, implants etc., on the other hand. He speaks English and German.