Medical devices

Certification

The entrance ticket to the international medical device market is ISO 13485 certification. With our accredited ISO 13485 and ISO 27001 certification service, we provide internationally recognized certificates. In addition, we support our Clients throughout the certification stage with a Notified Body.

Standard, legislation, guidance

Description

ISO 13485

Quality Management System

ISO 27001

Information security management system

ISO 9001, ISO 14001

Management Systems

MDR IX., XI. A.

Conformity assessment

Upon completion of above compulsory conformity assurance services the application for Conformity Assessment Procedure has to be placed at an independent Notified Body. The list of eligible Notified Bodies can be found at the following links:

MDR NB

IVDR NB

MD

EC type - examination or certificate of conformity (CoC) of production equipment

LVD

Certificate of conformity (CoC) of production equipment

EMC

EC type - examination or certificate of conformity (CoC)

RED

EC type - examination or certificate of conformity (CoC)

RoHS

Certificate of conformity (CoC)

ATEX

EC type - examination or certificate of conformity (CoC)

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