Clinical & Regulatory Consultant for Medical Industry

With more than 12 years of experience in the fields of regulatory affairs and  clinical trials, of medical devices and biotechnology in Europe and the US and wide skill based on in-depth knowledge of the European and FDA regulations, we can help you to comply with the requirements of worldwide regulatory organizations.

We provide full range of regulatory and clinical consulting services tailored to meet client-partners specific needs in the fields of regulatory affairs and clinical trials, as they relate to research and development of medical devices and related technology. We have the expertise to guide you through the entire complicated development process; from initial concept to regulatory plan, testing, pre-clinical, clinical trials, pre-marketing clearance and post-marketing compliance. We support the dynamic nature of this process with close, personalized relationship. We offer extraordinary degree of ethical and scientific standards and provide high quality professional service.

The consulting services are provided and led by Dr. Malca Chen-Zion with Ph.D. in Biology with highest distinction from Bar-Ilan University. She has a lot of experience in regulatory, clinical and preclinical strategic planning.  In the last 12 years, Malca held various management positions serving as Clinical Affairs director at Topspin Medical, which develops cardiovascular medical device and at Neurovision Ltd, which develops software medical devices. Malca also served as Vice president, Clinical and regulatory affairs director at Optonol Ltd., which develops Ophthalmic medical devices for permanent implantation. In the last years she is a consultant of various companies in different fields such as cardiology, ophthalmology, dental, gastroenterology and others.

Malca Published over 20 articles and 15 abstracts in the professional literature.