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Conformity assessment

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

dla kogo  For whom: for producers (OEM or OBL).

zakres  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.

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

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

MEDDEV s.c
Mydlarska 47
04-690 Warsaw

phone: + 48 22 300 54 31
mobile:+48 508 354 544
mobile: +48 791 480 270
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