Amir P.

PROFESSIONAL SUMMARY With over two decades in the medical device sector, I am a seasoned Senior Medical Device Consultant offering comprehensive expertise in global marketing authorization, EU MDR compliance, and robust quality management systems. My specialization lies in ensuring medical device product compliance, spearheading both internal and external audits, implementing advanced risk management strategies, and guiding post-market procedures. My proficiency extends to the design and management of Unique Device Identifications (UDIs), and I possess a deep understanding of Software as a Medical Device (SaMD). Having hands-on experience with a spectrum of international regulatory frameworks, I am adept with guidelines from the FDA, EU MDR, MDSAP, MHRA, PMDA, JPAL, TGA, and ANVISA. My extensive knowledge also covers critical areas like distribution selection and liaison with local competent authorities. This ensures that the products not only meet global standards but also align with regional and local compliance requirements. In my consulting capacity, I've consistently been the trusted advisor to senior and executive management teams of my clientele. I provide strategic direction, clarity on compliance obligations, and navigate the ever-evolving landscape of medical device regulations. Furthermore, I offer companies' executive teams pointed direction on imperative action items and provide invaluable insights on managing relationships with distribution networks and local regulatory bodies. PROFESSIONAL SERIVCES 1. Global Marketing Authorization 2. Regulatory Compliance 3. Quality Management Systems (QMS) 4. Post-Market Surveillance (PMS) 5. UDIs Management 6. Clinical Evaluation 7. International Council for Harmonisation (ICH) 8. Medical Device Software (MDSW) & Software as a Medical Device (SaMD) 9. Data Protection Impact Assessment (DPIA) EDUCATION • BSI, AU - Management Systems Auditing, 2018 • BSI, ISO 13485:2016 Internal Auditor (TPECS), 2018 • BSI, MD - Medical Devices Quality Management Systems, 2018 • American Society for Quality, ASQ-Certified Six Sigma Green Belt, 2008 • Mohawk College, Mechanical Engineering, 2001-2004