Person Responsible for Regulatory Compliance (PRRC) under Article 15 EU MDR 2017/745. Member of Team-PRRC. Currently responsible for Class I medical device (ALS Shock Clock) in pre-market phase. Responsibilities include: regulatory compliance, quality management system (QMS), post-market surveillance (PMS), vigilance and calamity reporting, technical documentation, and market release of Class I medical device (ALS Shock Clock).