With over 22 years of experience, primarily in the medical device industry, I've excelled as an auditor and assessor across various countries including India, Italy, and Myanmar. Specializing in ISO standards like ISO 13485 and ISO 17025, I conduct audits for CE certification, CDSCO license compliance, and ZED assessments. My technical expertise spans sterilization processes, equipment validation, and quality management systems. I've collaborated with notable bodies like Intertek, MTIC Intercert, and Bureau Veritas, ensuring adherence to regulations such as MDR 2017/745 and MDD/93/42/EEC. My extensive experience and certifications in risk analysis, software validation, and medical device standards make me a trusted professional in ensuring quality and compliance in the medical device sector.