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CE Marking

For legal manufacturers of medical devices we offer conformity assessment procedures according to Directive 93/42/EEC 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). 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.