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.
IVDR Compliance
EXCO supports a manufacturer of pre-analytical diagnostic systems on the way to achieving IVDR compliance.
MDR Compliance Implant Medical Products
EXCO ensures compliance with the Medical Device Regulation EU 2017/745 (MDR) and supports and trains clients in the transition.
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.
Safety testing of IVD, laboratory and medical equipment
EXCO is completing the required electrical measurements of devices together with the mechanical tests to ensure conformity to standards.
Gap analysis for existing product files
Gaps have been identified in the documentation of existing product lines. EXCO is creating a requirements list in order to close the gaps. The subsequent TÜV audit has been successfully passed.
Organization of an FDA audit
EXCO is preparing a customer for a pending FDA audit. EXCO is creating a detailed audit plan based on FDA 21 CFR Part 820 requirements and is completing a mock audit.
