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About Medical Devices pathway
Our Experience
Ms. Dzhafarov brings years of experience as a quality and regulatory professional with diverse product portfolio experience in the regulated medical devices industry. She has a background in quality systems and software quality engineering, and experience managing multi-location organizations. In those roles, she has had the opportunity to have critical impact on developing and bringing device innovation to markets in US, EU, Canada, S. Korea, Argentina, Australia, China, Japan, Brazil and Argentina. Ms. Dzhafarov has assisted organizations in achieving successful ISO 13485 certification, MDSAP certification, FDA breakthrough device designation, FDA clearances and approvals, NMPA approvals, MFDS approval, CMDCAS approval and CE marking, and have developed 513g, pre-submission/q-submission, BDD, De Novo, PMA, EFS, EUA, clinical trial submission documents (AUS, US, EU) and 510k submissions across various product lines. She is proficient in risk management, clinical/regulatory strategy, quality systems program management, sterilization validation and process monitoring, bioburden analysis, product project management, international standards and regulation gap analysis, software classification and validation, GDPR assessment and compliance, materials compliance and am well-versed in general manufacturing engineering principals.
Device Technology Experience
- Digital therapeutic, CBT to treat weight loss
- Diagnostic AI, CKD progression
- CPR positioning
- Digital therapeutic, CBT to treat anxiety
- rPPG, vital signs monitoring
- Cold compression therapy
- Digital therapeutic, CBT, depression in cancer patients
- NIV, heliox
- Digital therapeutic, fertility
- Digital therapeutic, swallowing rehabilitation
- Continuous ventilator
- Bronchoscopic ablation therapies
- Digital and scanner device, postural diseases
- Ophthalmologic ultrasound
- Digital therapeutic, arrythmia detection
- TAVR CEP
- Ambulatory monitor
- Radiological Image Processing
- PoC Ultrasound
- Digital goniometer
- Orthopedic implant, FMTP
- DNA sequencer
- HPLC Electrosurgical monopolar sealer
- Oximeter
- Balloon endoscope
- Automated platelet aggregation
- Selective cytopheretic device
- LVAD placement accessories
- Infrared therapeutic devices
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