Medical Devices

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.

Source: Medtech Outlook

The Product Compliance Portal: ROGER WILLCO

Companies offering their products for sale in Europe and elsewhere find themselves confronted with a growing number of regulatory requirements in relation to the initial research of market authorization requirements as well as the obligation to keep up to date – tasks that are difficult to master without expertise and support.

Some companies have in-house experts who can take on these projects.  However, even they also need a central tool that can collate and manage the necessary information on market authorization requirements and legislation.  In addition, they also need an early-warning system, which automatically alerts them to all relevant new regulatory requirements as they come into force in the respective markets.

In response to this situation, GLOBALNORM developed a tool that meets those requirements: ROGER WILLCO.