Sasha Gelfand
QA&RA Consulting, Medical devices
I’m an electronics engineer specializing in regulatory compliance and quality assurance for medical devices, with certification as a BSI ISO 13485 Lead Auditor, TÜV SÜD MDSAP Internal Auditor and MDR Expert, and ISO/IEC 27001 Lead Auditor. I bridge the gap between engineering and regulatory languages, ensuring seamless collaboration between teams. My expertise includes MDR compliance, product safety (IEC 60601), risk management (ISO 14971), and medical software (IEC 62304). I also manage DHF documentation, post-market surveillance, and labeling to streamline regulatory processes and achieve compliance.
