The application and technology of medical devices encompasses a broad spectrum and undergoes dynamic developments. Medical devices improve quality of life and even save lives.
Specific legislation, as well as various quality standards, have been developed in order to ensure the devices’ safety and performance, which are essential for patients and users. This is due to the fact that patients relying on the products often cannot make their own choice. A high level of expertise is required not only from manufacturers and their respective subcontractors and service providers, but from the certification bodies as well.
For legal manufacturers of medical devices we offer conformity assessment procedures according to Regulation (EU) 2017/745 as a Notified Body (EU identification number „0483“). Conformity assessment with the involvement of a Notified Body is mandatory for all manufacturers of medical device products with the exception of class I (non-sterile, no measuring function and not reusable surgical instruments). Our main activities involve not only on-site audits of a manufacturer’s quality system and associated subcontractors, but the assessment of Technical Files of the respective products as well. For these activities we provide both trained auditors and a range of experts whom possess years of experience from industry, testing laboratories, hospitals, and Notified Bodies.
The demand for a voluntary certification, according to QM standards, has increased during the last several years. This holds especially true for suppliers of components, semi-finished products, as well as for subcontractors and service providers for the medical device industry. A certificate according to EN ISO 13485, issued by a registrar which is recognized as a Notified Body, is a real benefit. Usually manufactures consider the availability of a certificate according to EN ISO 13485 as evident, and the frequency of supplier audits are significantly decreased by the manufacturers’ Notified Bodies. In parallel with EN ISO 13485 the compliance with specific technical standards (e. g. validation standards for sterilization procedures) may be confirmed.