As experts for medical devices, our customers have high expectations regarding the quality of our services. To do this claim justice we have decided to be voluntarily certified according to ISO 9001 and EN ISO 13485. Furthermore, NEMIUS is an accredited consultant of the Federal Office of Economics and Export Control.
As a competent partner of the healthcare industry, we have a 360-degree perspective. In addition to the classic consulting business for the approval of medical products, our product portfolio also includes training, interim management (turnaround) and start-up support.
Our integrated management system is based on the normative requirements of ISO 9001:2015, EN ISO 13485:2016 and the regulatory requirements according to the Medical Device Regulation (EU) 2017/745 (MDR) and In-Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR).
Our integrated management system (IMS) enables NEMIUS to be successfully accredited as an approved consulting company by the Federal Office of Economics and Export Control. In addition to the international requirements, our IMS also combines the following:
- those of the ICEM seal of the German Association of Surveyors and Experts,
- those of the Diversity Charter for Diversity Management and
- the German Heart Foundation.
Furthermore, our quality management system is based on the "Business Excellence System" of the European Foundation of Quality Management (EFQM).
Thanks to our continuous internal and external review of our own requirements and those of supervisory authorities (Notified Bodies / Certification Bodies), our customers have the security to consistently receive the highest level of performance.