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.
NSF
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 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 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.
