Michael Schaefer Quality Management and Regulatory Affairs

Michael Schaefer Quality Management and Regulatory Affairs is a consultancy and training service dedicated to Quality Management Systems (QMS) and Regulatory Affairs in the medical devices industry. Led by Michael Schaefer, a mechanical engineer with over 20 years of experience, the company specializes in areas such as process validation, design control, risk management, and regulatory compliance, adhering to standards like ISO 13485 and the Medical Device Regulation (MDR). The company offers expert consultancy on quality systems implementation and regulatory affairs, along with external training courses on topics including MDR compliance, CAPA, and internal audits. Additionally, it provides freelance support and technical writing for quality management and regulatory documentation. Michael Schaefer is a notified body Lead Auditor for ISO 13485, MDD, MDR, and MDSAP audits, highlighting his expertise in compliance and auditing. Targeting medical device manufacturers and quality practitioners, the company aims to enhance quality management systems and ensure regulatory compliance, ultimately focusing on patient safety and effective risk management practices.

• Employees 1
• Founded 2014