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 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.

Our services in the field of product certification for medical devices

  • 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 humans, achieve their primary effects through mechanisms other than pharmacological, immunological, or metabolic actions. Before entering the European Economic Area (EEA) market, the medical devices need to be compliant to applicable legislation and obtain the CE marking.
  • Medical Devices in the UK | Kiwa UK
  • The possibility of entrusting a competent body with the evaluation of electrical products for consumer and professional use is an advantage that manufacturers can benefit by turning to the experience and professionalism of Kiwa Italy and its specialized staff.