Medical Devices
Medical Devices are a heterogeneous category of products, such as active equipment, implants, reusable instruments, substances and materials, Sw, and more, intended for use on humans and therefore their safety and performance are of vital importance. To be put on the market and traded in EU, medical devices must comply with pertaining European legislations.
With a worldwide presence and a wide and in-depth experience in the medical field with several thousand certified devices in over 25 years of activity, Kiwa can provide complete and reliable information on the appropriate medical devices certification process to undertake, and deliver trusted conformity assessment activities and related services.
Kiwa services for the Medical Devices sector
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.
Quality Management System Certification
Be successful in the Medical sector and meet ever-changing market demands requires clearly defined processes and continuous improvement at every stage - from development to sales. Quality management systems accepted internationally and by the sector bring together all important information within the company and improves business operations.
Laboratory Services
Testing services for medical devices are functional to demonstrate products will reliably and safely be performing in use, for a preventive protection of end-users. For this, Medical Devices must be subjected to rigorous testing in order to meet the highest quality standards.
Training Courses
Kiwa, through its training companies offer a comprehensive range of medical device training courses carried out in line with the company strategies and the social transformations of the health sector and of the production and marketing of medical devices.
The new regulations on medical devices
Read more about the regulatory framework on the European Union website
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How do I get my medical device certified?
The procedure to follow to obtain the CE Mark can be different depending on the risk of the medical device and it needs to meet the essential requirements defined by the (EU) 2017/745 Regulation and subsequent amendments.
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Technologies and devices Kiwa can certify
For Class IIa, Class IIb and Class III devices, Notified Body’s conformity assessment is always required. Find out the technologies and devices Kiwa can certify according to Medical Device Regulation EU 2017/745.
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EU information and factsheet for manufacturers
The EU has a competitive and innovative medical devices sector, characterised by the active role of small and medium-sized enterprises. It is supported by a regulatory framework that aims to ensure the smooth functioning of the internal market, taking as a base a high level of protection of health for patients and users.
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Why choose Kiwa for your CE marking approval?
For over 25 years, thanks to a global presence and an in-depth experience in the medical field with several thousand certified devices, Kiwa has provided trusted conformity assessment activities worldiwide.
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