Due to expansion and purchase of a new manufacturing location in Germany, the process landscape of a client had to be adapted to ensure compliance with the new EU regulation IVDR ((EU) 2017/746).
EXCO was commissioned by the client's Regulatory Affairs and Quality Assurance department to assess the existing development process for regulatory and legal compliance with the EU IVDR.
The following tasks were defined:
- Performance of a GAP analysis, evaluation and adaptation of the Regulatory / Quality Guidelines to relevant regulatory and legal requirements
- Ensuring the regulatory compliance of processes and products, taking into account the quality requirements of ISO 13485 and the new EU IVDR
- Cross-departmental implementation of processes and coordination
- Advice and support for process managers in creating, managing and maintaining the processes
The client’s product portfolio and the related development processes were assessed using a gap analysis. The necessary steps to align with the process specifications were taken: existing specification documents were revised, missing ones established and integrated into the process. It was particularly challenging to develop Asian suppliers with regards to IVDR compliance: EU requirements had to be met and a component-specific approach had to be chosen that did not require a new approval.
These requirements were met and regulatory compliance was achieved by adapting the process related system architecture.
The new IVDR has more stringent requirements - EXCO supports customers in fulfilling them reliably.
- New approval of purchased products not required
- Compliant and audit-proof process landscape
- Time and cost efficient support of the RA and QA team in the implementation of the transfer
Pre-analytical system manufacturer, Switzerland / Germany