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MEDICAL DEVICES:

Comprehensive product compliance expertise for healthcare companies and their medical devices and compliant medical products worldwide


You're a manufacturer or importer of medical devices?  Then you would know that this group of products is tightly regulated by the authorities.  And that's a good thing, because the certification of medical devices serves to protect the health and wellbeing of patients.

 

 






We are your competent partner for the approval of medical devices on international markets.


Our expertise for manufacturers and importers of medical devices is vast.  Take advantage of our wide range of services today!
 

Our experts

Our network of specialists



Highest demands on product safety

A strong awareness of product compliance is already established in the healthcare sector, together with a firm grasp of existing regulatory requirements.  Accordingly, this has given rise to several occupations, such as the position of Regulatory Affairs Manager, for example, to be in charge of Standards and Product Compliance Management.  Staying informed on regulatory compliance requires continuous monitoring and management of the collected data, which are challenges that even Regulatory Affairs Managers or Product Managers in healthcare organizations often struggle to address. 


NEW: The medical device Regulation (MDR) 2017/745 in the EU

If your products are currently authorized under the Medical Device Directive (MDD) in the EU, then you'll very likely need to transition the CE marking of your products to the European legislation of the Medical Device Regulation (MDR).  We can analyze the current status of your product portfolio for you, highlight the most important changes enacted by the Regulation and actively assist in the transition to ensure you're ready to meet the new EU statutory requirements of the MDR 2017/745 by 2020 at the latest.

Product Compliance for medical devices

How may we help you?

Our expertise for manufacturers and importers of medical devices is vast.  Take advantage of our wide range of services today!

Meet the team

Our experts

Our network of specialists

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