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The process established by ISS AG for the preparation of clinical evaluations was again recognized by a positive assessment from a well-known Notified Body. "The clinical evaluation was established after MEDDEV 2.7.1 rev.4 and fulfills the requirements of MEDDEV 2.7.1 rev.4"

We are very pleased that we have been able to support our customers in the certification of a Class IIb implant.