We offer solutions for the regulated market. EXCO examines your processes and documentation for compliance with the requirements of the new EU MDR / IVDR. This includes individual consultation with recommendations for action and the specific implementation of entire work packages.
MDR / IVDR Scalable Services
EXCO enables the certification of your company and the marketing of your products according to MDR/IVDR. Following our GAP analysis, we will create a concept that is tailored to you, which can be implemented by us or together with your relevant department. As a result, your QM system including the supplement management system will be harmonized in relation to regulatory requirements and you will obtain technical documentation for your products which is legally compliant.
Technical Documentation as a Service
EXCO compiles the technical documentation/product files on the basis of your existing design documentation, re-engineering and/or developer interviews.
Pre-Compliance-Test
EXCO examines the technical documentation (according to MDR/IVDR Appendix II) and/or clinical evaluation and ensures that the product files contain no formal or technical discrepancies when they are delivered to the test laboratory.
Managed Product Care
EXCO accompanies significant changes carried out by the manufacturer’s development (deviation management) and ensures that risk management, technical documentation and clinical evaluations are up-to-date as required.
Managed MDR/IVDR Transfer
EXCO carries out the legally compliant transfer of technical product files licensed according to MDD/IVDR in accordance with the requirements of MDR/IVDR.
Advice on Possible Subsidies
EXCO provides advice on possible subsidies from the state or country for activities relating to a managed MDR transfer.
Supplier Management
- Consultation concerning the requirements derived from the MDR/IVDR on the subject of supplier management/development
- Integration of FDA 21 CFR Part 820.50 requirements on “Purchasing Controls” into existing processes and customer-supplier relationships
- Definition and implementation of outsourced processes
- Supplier and service provider qualification
- Process validation, plant qualification
- Planning, execution and follow-ups of supplier audits
- Creation of quality-assuring contacts and agreements (QSVs)
- Risk management for products and integration of the supplier
Management and mentoring of supplier transfers (knowledge, processes, physical relocation)
