"Re-Validation of Medical Devices"

There is no industry-specific regulation for the validation of cleanliness in medical devices that prescribes uniform and binding procedures as well as acceptance criteria. Medical technology companies therefore rely on standards from other cleanliness-critical industries, such as pharmaceuticals, often without sufficient adaptation. High effort, unnecessary costs, and sometimes ambitious limit values combined with low significance of the analysis results are common consequences.

The affected medical technology companies now wish to jointly promote standardization in this area within an industry consortium. This was the outcome of a workshop at Fraunhofer IPA. The goal of the consortium will be to determine the current state of cleanliness and cleaning validation and, based on this, to jointly develop practical and uniform procedures as well as pathways to acceptance criteria.

An opportunity for active participation:

Fraunhofer IPA offers all interested parties to moderate the consortium as a technical and independent partner and to provide the infrastructure for an open and targeted collaboration of medical technology companies. The technical work of the industry consortium will begin on March 26, 2015, with a kick-off workshop, to which we warmly invite all interested parties to participate. Those who also become part of the consortium can take the opportunity to actively shape solutions.

Participation:

No participation fee (Kick-Off Workshop). Upon registration, the offer to participate in the industry consortium will be sent.

Venue:

Fraunhofer IPA, Stuttgart

Date:

March 26, 2015

Contact:

Guido Kreck
Fraunhofer IPA
guido.kreck@ipa.fraunhofer.de