12th December 2024, Ljubljana

Regular training in the field of medical devices: PREPARATION FOR THE INSPECTION CONTROL OF THE IMPLEMENTATION OF THE OBLIGATIONS OF IMPORTERS AND DISTRIBUTORS OF MEDICAL DEVICES (Slovenian language)

Our regular training is aimed at distributors and importers of medical devices (i.e. import and wholesale and retail, specialized stores, pharmacies and other stores) who want to acquire the necessary knowledge about the regular inspection process carried out by pharmaceutical inspectors in the control market. of medical devices in the field of import and distribution.

The knowledge and guidance acquired during the training will provide you with:

✓ understanding how the medical device market is regulated and implemented under the MDR and IVDR;

✓ knowledge to prepare for a possible inspection control;

✓ insight into the process of inspection controls, including what inspectors check and what requirements they can make;

✓ practical instructions on how the company should prepare for the inspection and who should be present during it;

✓ how to act in case of identified deficiencies and how to act if the inspector is not satisfied with the evidence of their elimination;

✓ how to act if the inspectors’ requirements are not in accordance with the law and what measures you can use in such cases;

✓ understanding the various measures and penalties that can be determined by the pharmaceutical inspector and how to respond to them in accordance with the legislation;

✓ determining whether some simply fulfill obligations in the field of import and distribution of accessories and you still need to improve them in your existing business system.

Click HERE for more information on the workshop.

Click HERE to apply for the workshop.