Quality Management Systems

Education, Training, Quality Management

Information

Your company's quality management system (QMS) can help optimize performance, achieve cost savings and improve customer satisfaction. We can assist you with all quality management issues and tasks worldwide. Through our involvement in ISO TC210/WG1 and decades of experience, we work with you to find the most efficient and secure regulatory solutions for your business. NSF Prosystem can assist you with: - Implementing a complete quality management system in accordance with ISO 13485:2016 and ISO 9001:2015 requirements. - Evaluation of your QMS with regard to regulatory and normative requirements (e.g. ISO 13485:2016, 21 CFR 820 Quality System Regulation, Medical Device Single Audit Program (MDSAP), ANVISA: RDC 16/2013 and Regulation (EU) 2017/745) - Process optimization and further development of existing processes in accordance with regulatory requirements - Conducting internal audits and supplier audits - Training and further education of your quality management representative/PRRC - Preparation, support and follow-up of inspections and audits

Visit ID (prod)

16u0elcgxi9wx

NSF PROSYSTEM GmbHSA.M30NSF PROSYSTEM, an NSF international company, provides leading global consulting services in medical devices and IVDs. Our expertise and long-standing customer relationships help us shape the future of medical technology by identifying new opportunities, addressing and managing critical challenges.We are specialized in consulting and services in medical devices and IVDs including regulatory affairs, medical device registration, clinical evaluations, technical documentation, life cycle management, risk and quality management.As a member of various standardization groups, our staff is actively involved in developing standards such as ISO 13485, ISO 14971, IEC 62366-1, IEC 60601 and IEC 62304/82304-1, and in influencing normative policy decisions. By helping to shape standards, we strengthen your company’s competitive advantage.