Principal Consultant at Sushvin Consultancy
Luton, UK
IVDR/MDR Consultant, UK Responsible Person, SaMD specialist, AI in Healthcare, Lead Auditor, DHF specialist With 15 years of experience in the Medical Device and Pharmaceutical industries, I have honed my skills in various Regulatory and Quality functions. My strong business acumen is complemented by a focus on Regulatory and Quality compliance. I possess expertise in New Product Development and Project Management, built on a solid technical foundation. I have worked with different regulatory bodies and successfully navigated regulatory audits. Specialties: MDR/IVDR 510K Medical Devices UK Responsible Person ISO 9001 Lead Auditor ISO 13485 Auditor Technical File Review Risk Management and Cybersecurity SaMD (Software as a Medical Device) and AI (Artificial Intellegance) CER (Clinical Evaluation Report) DHF (Design History File) PMS (Post-Market Surveillance) UDI (Unique Device Identification) Label and IFU Artwork Review Device Global Registration Medical Device Product Testing






No guidelines added yet. Add your pitching preferences to help sources craft the perfect outreach.