QMS certification according to EN ISO 9001 standard
The EN ISO 9001 standard has been created with the aim of support successful operation for any organization, regardless of size or area of operation.
A quality management system is the most effective way to make optimal use of processes, human and other resources and to ensure high-level customer satisfaction.
Our certification activities according to the EN ISO 9001 standard are limited to certain areas of medical technology.
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. We offer supervision services of valid certificates which had been legitimately issued by us under directive 93/42/EEC on a contractual basis. We send quotation for supervision services at our client’s request.
According to the Article 120. of Regulation (EU) 2017/745, we offer our clients all round surveillance activities such as surveillance and unannounced audits or type examination in relation to valid certificates legitimately issued by us under Directive 93/42/EEC.
NEOEMKI LLC. is a notified body for conformity assessment according to Directive 93/42 / EEC.
From the introduction of Regulation (EU) 2017/745 (26 May 2021) NEOEMKI LLC. will not accept application for certification according to Directive 93/42 / EEC and will not make any modification or change on the certificates issued under the Directive 93/42/EEC.
In connection to validly issued certificates under Directive 93/42/EEC, NEOEMKI LLC. regularly perform the necessary unannounced visits. NEOEMKI LLC. follow guideline 473/2013/EU for unannounced visits (see amendment III. of the guideline).
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 such as surveillance and unannounced audits or type examination in relation to valid certificates legitimately issued by us under Directive 98/79/EC.