Certification according to (EU) 2017/745
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QMS certification according to EN ISO 13485 standard
The EN ISO 13485 standard is important for developers, manufacturers and distributors of medical devices. In addition, manufacturers are increasingly expecting their suppliers and service providers to be certified.
The application of the EN ISO 13485 standard is an effective solution to ensure that your company fully complies with the requirements against the quality management system.
The application of the standard provides a solid basis for manufacturers to meet the requirements arising from their legal and social responsibilities, while demonstrating their commitment to the safety and high quality of medical devices.
Supervision of MD certificates issued under directive 93/42/EEC
Regulation (EU) 2023/607 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL (15 of March 2023) amended transitional rules of regulation (EU) 2017/745 (MDR).
According to MDR Art. 120. 3e) NEOEMKI LLC. offers its supervision services for valid certificates which had been legitimately issued under directive 93/42/EEC until 26th of September, 2024 only.
Supervision of IVD certificates issued under directive 98/79/EC
NEOEMKI LLC. is a notified body for conformity assessment according to Directive 98/79/EC.
Certification process according to directive above must be concluded until 26th of May, 2022.
According to the Article 110 of Regulation (EU) 2017/746 (IVDR), we offer our clients all round surveillance activities in relation to valid certificates legitimately issued by us under Directive 98/79/EC.