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Medical Devices Regulations (MDR)

Medical Devices Regulations (MDR)

The new Medical Devices Regulations (MDR) – what you need to know!

the new Medical Devices Regulations (MDR), which must be fulfilled for CE certification as of May 2020
photo: iStock
CE mark according to MDR

The new Medical Devices Regulations (MDR) and the Active Implantable Medical Devices Directive (AIMDD) were published in May 2017. Its transitional period will end on 26 May 2020. From that date the MDR will apply fully.

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Transforming the MedTech Industry

Transforming the MedTech Industry

Transforming the MedTech Industry

transforming the MedTech Industry
Health Information Technology (HIT)
Internet of Medical Things (IoMT)
Digitization of Medical Healthcare
picture: IStock
Digitization of Medical Healthcare

August 2019 – Transforming the MedTech Industry – why is that the future?

According to a commissioned study of the United Nations, the world population will increase to 10 billion by 2050. 2 out of 5 people will be over 60 years old and 434 million over 80.

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Strategic distribution of medical devices in Europe

Efficiency increase of the strategic distribution of medical devices in Europe for SMEs

Juli 2019 – Many medical device companies aim to sell their products on European markets.  Their own budget bottlenecks allow only limited market opportunities. What are the reasons and what considerations should SMEs make to increase the efficiency of the strategic distribution of their medical devices?

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QB-Analyzer – analysis of the German hospital market

QB-Analyzer – analysis of the German hospital market

QB-Analyzer: Your online tool for the targeted analysis of the German hospital market 

Marketing and Sales Tool

The QB-Analyzer analyzes and digitizes “annually” all data of the quality reports of German hospitals. Therefore, it is interactive and web-based.

As a result, ideal for identifying market potential and efficiently managing sales. In other words, it is an online tool for the targeted analysis of the German hospital market.

QB-Analyzer for clinic targeting of German hospitals
QB-Analyzer, online-tool e.g. for perfect graphical representations
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Medical Devices Regulations (MDR)

Second Notified Body TUV Sued

TUV Sued is second Notified Body after MDR

CE Mark is awarded by Notified Body
photo: IStock
CE Mark is awarded by Notified Body

16.06.2019 – TUV Sued Product Service has been recognised by the “Central Office of the Countries for Health Protection with regard to Pharmaceuticals and Medical Devices” (ZLG) as the second Notified Body for the new Medical Devices Regulations (MDR) after the British-Dutch BSI.

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