Lead SME
Dr. Ava Mercer
4.9·312Former FDA reviewer, SaMD lead
- FDA QMSR
- SaMD
- Pre-Sub
- IEC 62304
£480/hr
Online & in-person
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Book 1:1 sessions with experts across FDA QMSR, IEC 62304, EU MDR, cybersecurity, AI/ML governance, and risk & V&V.
Showing 8 SMEs
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- Lead SME
Dr. Lena Voss
4.9·142AI/ML quality & GMLP specialist
- AI/ML
- GMLP
- EU AI Act
- Model Governance
Book session£460/hr
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- Lead SME
Rohan Patel
4.8·248Principal software engineer, medical devices
- IEC 62304
- SaMD
- DevSecOps
- Traceability
Book session£420/hr
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Sofia Ibarra
4.9·176Cybersecurity lead, connected devices
- Cybersecurity
- SBOM
- Threat Modeling
- FDA 524B
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Priya Desai
4.8·167EU MDR & IVDR regulatory strategist
- EU MDR
- CE Marking
- Notified Body
- Technical File
Book session£420/hr
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- SME
James Okafor
4.7·203Risk management consultant, ISO 14971
- ISO 14971
- Risk Management
- FMEA
- V&V
Book session£380/hr
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- SME
Marcus Chen
4.6·189V&V lead, Class III SaMD
- V&V
- SaMD
- Test Strategy
- Traceability
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Noah Albrecht
4.7·38Secure SDLC architect
- DevSecOps
- SAST/DAST
- IEC 62304
- Cybersecurity
Book session£360/hr
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