Shahram Ahmadi Email & Phone Number

As a Regulatory Affairs and Quality Assurance specialist with a PhD in Materials Science and extensive experience in the medical device industry, I bring expertise in regulatory compliance, quality management, and manufacturing across a broad range of devices, including implants, PPE, and dermatological products. My specialization includes risk management, GSPR, labelling, UDI, clinical evaluations, PMS, and SOP development, with a strong focus on compliance with MDR and ISO 13485:2016 standard. I am a certified MDQMS auditor and serve as a Person Responsible for Regulatory Compliance (PRRC). Currently, I am further enhancing my expertise by pursuing an MSc in Medical Technology Regulatory Affairs at Atlantic Technological University (ATU), Galway, Ireland.