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.
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).
Optical sensors for medical devices
EXCO develops a supplier to confirmity with the medical industry. Valid products and production processes have been established.
MDR compliance implant manufacturer
EXCO ensures compliance with the Medical Device Regulation and supports clients in the transition.
IVDR Compliance
EXCO supports a manufacturer of pre-analytical diagnostic systems on the way to achieving IVDR compliance.
