The Auditor, based in Pune, Maharashtra, India, boasts extensive expertise in Quality Management Systems (QMS) and CE marking within the medical device sector. With a background in Biochemistry and Chemistry, they conducted audits and gap analyses in collaboration with European notified bodies. Their career spans roles in quality control at TTK Biomed and Pregna International, ensuring compliance with ISO standards and regulatory requirements. As a CE auditor and operations manager at MOODY ICL Certifications Ltd, they certified organizations for CE marking and ISO 13485:2003. Additionally, they offer consultancy and training, aiding numerous medical device manufacturers in achieving regulatory compliance and enhancing quality management practices.