NSF PROSYSTEM GmbH

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NSF PROSYSTEM GmbH

Our organization

PROSYSTEM AG was founded in Hamburg in 1999 and today serves more than 400 companies in the medical device and pharmaceutical industries worldwide. In 2017, PROSYSTEM merged with NSF to form NSF PROSYSTEM GmbH.

NSF is an internationally recognized health organization with headquarters in Ann Arbor, Michigan, USA. Since 1944, NSF has employed more than 3,000 people at 60 office and laboratory locations worldwide and provides health services in more than 180 countries. NSF is also a World Health Organization (WHO) collaborating center for food safety, water quality and medical device safety.

ISO 9001

Quality management system according to ISO 9001

NSF PROSYSTEM GmbH maintains a quality management system in accordance with ISO 9001 with the following scope:

  • Clinical evaluations and studies for medical devices
  • Performance evaluations and performance studies of In-vitro diagnostic devices
  • Biological assessments to evaluate biological safety
  • Post-market surveillance
  • Consulting on regulatory requirements and quality management for medical devices and In-vitro diagnostic devices
  • Planning and implementation of congresses, seminars, training courses and workshops

ISO 13485

Quality management system according to ISO 13485

In addition, NSF PROSYSTEM GmbH maintains a quality management system according to ISO 13485 for the assessment, creation and maintenance of the technical documentation for medical devices as well as associated regulatory services.

Support

On the way to success

NSF combines first-class consulting and services to support companies on their path to success. With many years of experience and in-depth expertise in the areas of quality management, regulatory affairs and clinical affairs, NSF offers customized solutions to meet the specific requirements of manufacturers and help them achieve their goals.

As a member of national and international standardization working groups, NSF actively participates in the development of important standards and can thus strengthen the competitive position of its customers in the long term and sustainably.

Our values
Quality assured

Our dedicated team of highly qualified experts ensures the highest standards in implementing your requirements. We focus on quality to ensure the safety of patients, users, and third parties by complying with all relevant regulatory requirements.

Effective and flexible

Our services are customized, pragmatic, and flexible. We offer customized solutions, quick decisions, and continuous monitoring to ensure the highest efficiency. Our flexibility allows us to adapt to changing situations at any time, thus achieving the best results.

Reliable

We are a reliable partner, for both short-term inquiries and extensive projects. In addition to our services, we offer comprehensive consulting and training. Our goal is sustainable collaboration that ensures long-term success.