Trainings and services

EMKI-cert ft. provides training and conferences for companies operating in the field of medical technology.

The organisation of training courses and professional conferences we pay attention to the independence and impartiality requirements for conformity assessment bodies and therefore

-  our training courses and conferences are published on our website so that all stakeholders have access to them without discrimination,
-  we do not undertake training or presentations organised by a client at the client's premises with the client's exclusive participation,
-  our courses are freely accessible (free of charge or by subscription) without any restrictions on participation, preferably in an online format

Available educations

Information on the legal placing on the market of bed head unit systems

The presentation aims to provide a proposal for typical questions in the certification of bed head units, based on Regulation (EU) 2017/745 (MDR) and its predecessor 93/42/EEC.
The proposal is based on many years of experience, takes into account EU guidelines on the regulation of medical devices and aims to establish a coherent system.
However, this presentation reflects the position of EMKI-cert Ltd. for its own procedures and cannot guarantee that any other Notified Body or competent authority will take an equal position.
Major themes:
-    definition
-    the justification for medical device classification
-    requirements for the content of technical documentation
-    conformity assessment process

Information on the legal placing on the market of gas supply systems

The presentation aims to provide suggestions for typical issues in the certification of medical gas supply systems, based on Regulation (EU) 2017/745 (MDR) and its predecessor 93/42/EEC.
The proposal is based on many years of experience, takes into account EU guidelines on the regulation of medical devices and aims to establish a coherent system.
However, this presentation reflects the position of EMKI-cert Ltd. for its own procedures and cannot guarantee that any other Notified Body or competent authority will take an equal position.
Major themes:
-    the justification for medical device classification
-    definition
-    direct and indirect sources for the conformity assessment of gas supply systems
-    questions arising during conformity assessment
-    certification of gas supply systems
-    conformity assessment routes

Questions of classification in MDR on the basis of rule 22 of the annex VIII.

The presentation intends to formulate a proposal for Regulation (EU) 2017/745 (MDR) for the interpretation of rule 22 of Annex  VIII.
The proposal is based on many years of experience, takes into account EU guidelines on the regulation of medical devices and aims to establish a coherent system.
However, this presentation reflects the position of EMKI-cert Ltd. for its own procedures and cannot guarantee that any other Notified Body or competent authority will take an equal position.
Major themes:
-    sources
-    rule presentation
-    interpretation related to the built-in diagnostic function
-    closed-loop, physiological closed-loop control forms, as well as physiological closed-loop control with built-in diagnostic function
-    examples based for class III. classified devices on Rule 22

Please contact our office on +36 30 143 4642 for details or look for our announcement in the "News" section for current training courses.