Mark Shmurak

Mark Shmurak

Senior RAQA Consultant

Mark Shmurak, M.Sc. RF Electronics, CQE, and RA graduated specialist with 30 years of experience in the worldwide Medical Devices Industry of various Products of all risk classes, which were successfully US FDA and EU CE Mark approved.

Mark Shmurak has a strong Technical, Quality Management, and Regulatory Affairs background. More than 3 years of experience in consulting medical devices companies at HaMaDa in the position of Senior RAQA Consultant.

In his prior experience, Mark has held various positions including: RAQA & Engineering Director, QA Manager, Quality Expert, and more.

Medical Application fields: ophthalmology, dental, delivery system, cardiology orthopedics, OB/GYN, diabetics, oncology, genetics, gastroenterology, surgery navigation, radiology, telemedicine, surgical instruments, rehabilitation wound care, and others.

Mark Shmurak is Lead auditor for ISO 13485, QSR, MDR, and MDSAP compliance and Lead auditor for ISO 27001 compliance.