Product Certification

The issue of product safety is now a priority for every manufacturer, as is the importance of knowledge of legislation and regulations to ensure the ultimate goal of 'preventive protection' for the consumer.

Thanks to Kiwa's expertise, medical device companies can demonstrate that they meet the essential requirements for medical devices and gain access to the European market, as well as obtaining prerequisites for access to other global markets. In addition, thanks to Kiwa Italia's technical expertise, medical device manufacturers can rely on a trusted partner that can guarantee the execution of an effective conformity assessment process, which can combine a guarantee of market protection with a business tool.

Our services in the field of product certification

  • As a Notified Body (NB 0476) performs conformity assessment activities for issuing EU certification in accordance with Regulation (EU) 2017/745 (MDR).
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  • Learn more about the Medical Device Certification process according to Directive 93/42/EEC and the new features of Regulation (EU) 2023/607. Kiwa Cermet Italia offers support for the extension of MDD certificates and compliance with Regulation (EU) 2017/745, ensuring effective surveillance and assessments.
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