Conformity assessment

  Objective: Preparation of documentation necessary for product marking with the CE mark and / or  for product assessment by a notified body.

  For whom: for producers (OEM or OBL).

  The scope of services depends on the quality of the product documentation:

• Clinical evaluation of a medical device (assessment based on the available literature, medical reports, clinical trials).
• Consultations with a notified body in the field of conducting clinical trials (class IIa, IIb, III).
• Risk analysis of the medical device in terms of the safety of users according to ISO 14791: 2012.
• Developing procedures for supervision of the product in accordance with ISO 13485 (instructions and forms)..
• Preparing instructions for use of a medical device in accordance with the requirements of medical directive and national regulations.
• Development of format and content of labels and packaging.
• Supervision of the certification process.
• Development of the draft of conformity declaration for the product.

​  Benefits: Risk reduction resulting from conducting the process of conformity assessment by professionals. 

  The cost and time necessary to deliver the service depends on the class of the product.