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.
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).
