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Cybersecurity checklist for authorisation within the EU

As part of the approval process, the customer wants to test the cybersecurity of a medical device (a laser hair removal device).

EXCO Services
  • Creating a cybersecurity checklist in collaboration with the customer
  • Risk assessment in the form of an Excel spreadsheet, GAP analysis as a presentation
  • Assessment of the product's conformity with standards in accordance with EU Regulation (MDR) 2017/745, taking into account the additional guidelines MDCG 2019-16, MDCG 2022-21 and the standard IEC 81001-5-1
Client benefits
  • Identification of appropriate measures based on the risk assessment carried out, which contribute to the conformity of the medical device with standards
  • Improved customer understanding of the requirements of relevant standards
  • Independent prioritisation of the identified measures by the customer
Client

Manufacturer of medical devices using laser technology

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