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NEOEMKI LLC.
OUR SERVICES
Contact Us
MDCG guidelines and Mandatory documents
Magyar

NEOEMKI LLC.
OUR SERVICES
Contact Us
MDCG guidelines and Mandatory documents
Magyar

MDCG guidelines and Mandatory documents

You may find the MDCG endorsed documents here.

Download center

Certification ISO 13485:

Quotation form EN ISO 13485

Change request form ISO

General Terms and Conditions (ISO)

Rules for certification symbol usage

Standard fees and rates (ISO)

Certification MDR:

Quotation form MDR

General conditions for quote request

Article 117. form (MDR)

Change request form MDR

Application form MDR

Device list for application

General Terms and Conditions (MDR)

Instruction for uploading files

Standard fees and rates (MDR)

General:

Complaint form

Appeal form

Management declaration

Headquarters: H-1097 Budapest Albert Flórián út 3/a.

Postal address: H-1463 Budapest, Pf. 853.

Phone: +36-20/268-7595

Email: cert@emki.hu | titkarsag@emki.hu

Keresés

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© NEOEMKI Kft. 2025.

NEOEMKI LLC.
OUR SERVICES
Contact Us
MDCG guidelines and Mandatory documents
Magyar