ISO 9000 describes the concept of quality as the ability to satisfy customers. In medical technology, this approach alone is not enough. Maintaining and implementing regulatory requirements is at the forefront of each phase of the product life cycle of each medical device.

The quality management system (QMS), in accordance with ISO 9000, includes activities that help the organization identify its objectives and determine the processes and resources required to achieve the desired results. ISO 13485 clearly states that the primary goal of any organization involved in one or more stages of the lifecycle of a medical device is safety and performance, and compliance with regulatory requirements.

We can support you with all questions and tasks concerning quality management worldwide. Through our involvement in ISO TC210/WG1 and our decades of experience, we work with you to find the most efficient and secure regulatory solutions for your business.
NSF International gladly supports you in:

  • Implementation of a complete quality management system in accordance with the requirements of ISO 13485:2016 and ISO 9001:2015
  • Assessment 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
  • Conduct of internal audits and supplier audits
  • Training and further education of your quality management representative
  • Preparation, support and follow-up of inspections and audits

NSF International is your reliable colleague in building your quality management system and actively supports you in maintaining the effectiveness of your QMS. We work with you from the creation of your QMS documentation to certification by your notified body. In addition, we help you to constantly improve your processes and make sure that the compliance of your processes is maintained despite regulatory changes.

The NSF Academy offers you various courses and seminars in quality management.

For further details on the subject of quality management or for a non-binding offer, please contact us.