Clinical Strategic Consulting
Consulting for the development and clearance of innovative clinical tools
Our Services
Regulatory Affairs
Product Development
Clinical Research
Quality Compliance
Training
Auditing
About
Mirit Dekel Dahan, Ph.D.
Owner and Senior Clinical and Regulatory Affairs Consultant
Mirit is recognized as an expert in clinical development of medical devices and their representation to the regulatory authorities as well as a BSI certified ISO 13485 Lead Auditor. Her career is at the focal point of science, technology, regulation, and healthcare. She focuses on regulation of innovative products in treatment and diagnostics in many fields – CNS, oncology, neuropsychology, cardiology and biologics. She also has substantial experience characterizing and analyzing medical big-data and has been at the forefront of several of the most recent approvals of innovative AI based medical devices.
Shira Alchanati, M.Sc.
Clinical and Regulatory Affairs Manager
Shira is a Technion graduate with a degree in biomedical engineering. Her master's thesis included signal and image processing of ultrasound images. In the past two years, she has specialized in regulatory affairs management for medical devices. This includes scientific research according to state-of-the-art technologies, clinical evaluation studies and reports, and submissions to regulatory entities according to the device's classification, development stage and unique design.
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ISR. (Office):+972 4 9919550
ISR. (Mobile):+972 52 6134335