NPE Systems' BSI Certificate of Registration certifies that their Quality Management System complies with the requirements of ISO 13485. This international standard specifies the requirements for a quality management system to be used by an organization for the design and development, production, installation and servicing of medical devices, and the design, development and provision of related services.

This ISO certification demonstrates NPE System's ability to design and test medical devices and offer related services that consistently meet customer and regulatory requirements.  Mayra Bisnow, Quality Systems Manager at NPE Systems, has 30 years of experience in Validation and Verification and Quality Systems Management in the IVD industry.  Mayra‘s strength is in ensuring that development teams follow a quality controlled development process resulting in IVD product approvals and/or ISO certification for CE marking.  Clients can count on NPE's well defined and clearly understood quality system.