Valentina Zhutovski

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Valentina Zhutovski

Senior RAQA Consultant

Valentina Zhutovski, M.A. Quality Management and Statistics, has extensive experience of over 15 years in establishing, improving, maintaining and executing quality and regulatory strategies across various medical industries for global corporations and start-ups. Valentina has a proven track record in obtaining regulatory approvals for Class II and III medical devices, as well as highly classified In Vitro Diagnostic (IVD) devices and Software as a Medical Device (SaMD), ensuring strict compliance with international standards. Valentina has previously held senior roles at leading global medical companies, navigating complex regulatory landscapes and leading product registrations.

Range of products

Diagnostic & therapeutics, MD, SIMD, SAMD, IVD (in vitro diagnostic devices), companion diagnostic, combination devices, complex active systems, clean, sterile, biocompatible, single-use, reusable devices, home use equipment, OR equipment, Pharmaceuticals, Biologics, Genetics.

Therapeutic Areas- Treatment and Diagnostic Devices

Cardiovascular, Endocrinology & Metabolism (Diabetes, Osteoporosis), Urology, Infectious diseases, Ophthalmology, Gynecology, Musculoskeletal, Neurology, Neurosurgery, Dentistry, Plastic Surgeries, Esthetics, Pain, Pediatrics, Neonatology, Oncology, Orthopedics, Respiratory, Esthetics.

Valentina Zhutovski