EXCO - Your Trusted Partner for ISO-Certified Quality
Discover our project references and learn how we support our customers in GxP-regulated environments with proven, practical solutions.
Internal audits for SMEs
EXCO supports customers in conducting internal audits in accordance with EN ISO 13485:2016/A11:2021, Section 8.2.4, and in preparing audit documentation that meets applicable standard requirements.
Cybersecurity checklist for hearing aid software
EXCO developed a checklist for conducting a comprehensive risk assessment after several audit deviations in the area of cybersecurity were identified at the customer's site.
Cybersecurity checklist for authorisation within the EU
As part of the approval process, EXCO was commissioned to test the cybersecurity of a medical device (a laser hair removal device).
Medical device approval (FDA) with a focus on cybersecurity
EXCO provided cybersecurity support to the client in connection with FDA approval of an operating-theatre medical device under the eSTAR programme.
Risk Management and Product Approval
EXCO prepares companies for product audits and evaluates risk management files.
Accompaniment of MDR Product Licensing
EXCO advises a medical device manufacturer on the new European Medical Device Regulation (MDR).
