IVDR Notified Body Certification
Sertio, a Kiwa company, provides independent IVDR Notified Body certification services for in vitro diagnostic medical devices, supporting global manufacturers in CE marking and achieving EU market access.
Product certification services (Medical Devices)
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 our 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.
CE Marking of Medical Devices in accordance with MDR
Medical Devices are an heterogeneous category of products, such as active equipment, orthopaedic implants, reusable instruments, substances and materials, software, and more. These devices, designed for medical purposes and intended for use in or on human...
CE marking of Medical Devices in accordance with the MDD
Kiwa Notified Bodies are able to provide all the necessary services to obtain comprehensive answers and reliable information on the Medical Device certification process in accordance with Directive 93/42/EEC.
Thanks to the experience of Kiwa Notified Bod...
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Would you like to know more about our services in the field of Medical devices? Please contact us using this form.