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.
Implementation of a QMS in accordance with DIN EN ISO 13485
In collaboration with EXCO, a client is implementing a quality management system in compliance with DIN EN ISO 13485.
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.
New QM-system for start-up
For a manufacturer of sterile medical products, EXCO creates a customized QM system according to 13485 and establishes the system within the customer organization.
