Compliance expertise for medical devices
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.
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.
GLOBALNORM – For the safest medical devices
In addition to the new Medical Device Regulation 2017/745, the expertise of our specialists also covers the In-vitro Diagnostics Ordinance 2017/746 as well as international market authorization requirements, such as those of the FDA in the United States. Our specifically developed IT solutions assist you in the efficient handling of normative and regulatory requirements.
We would be pleased to advise you on all aspects and issues of product compliance for medical devices!