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Webinar recording
In addition to labeling and packaging requirements, the US Food and Drug Administration’s (FDA’s) Unique Device Identification (UDI) regulation and the European Union’s (EU's) new Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) require certain devices to have UDI direct marking.
With the US Class I and EU MDR Class III direct marking compliance deadlines approaching, join us to learn about the differences in the requirements and strategies for compliance. USDM Life Sciences will address the requirements for US and EU MDR direct marking, FOBA will address how best to implement direct marking, and USDM will also provide QMS and validation guidance for direct marking.
This discussion will include:
- US Class I and EU MDR Class III direct marking compliance requirements
- Nuances and differences in the US and EU requirements
- Strategies to address the differences and simplify your UDI and validation efforts
- Implications to your Quality Management System (QMS)
and get access to the webinar replay and the documents below.
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Lorem ipsum dolor sit amet, consetetur sadipscing elitr, sed diam nonumy eirmod tempor invidunt ut labore et dolore magna aliquyam erat, sed diam voluptua. At vero eos et accusam et justo duo dolores et ea rebum. Stet clita kasd gubergren, no sea takimata sanctus est Lorem ipsum dolor sit amet. Lorem ipsum dolor sit amet, consetetur sadipscing elitr, sed diam nonumy eirmod tempor invidunt ut labore et dolore magna aliquyam erat, sed diam voluptua. At vero eos et accusam et justo duo dolores et ea rebum. Stet clita kasd gubergren, no sea takimata sanctus est Lorem ipsum dolor sit amet.
Lorem ipsum dolor sit amet, consetetur sadipscing elitr, sed diam nonumy eirmod tempor invidunt ut labore et dolore magna aliquyam erat, sed diam voluptua. At vero eos et accusam et justo duo dolores et ea rebum. Stet clita kasd gubergren, no sea takimata sanctus est Lorem ipsum dolor sit amet.
Lorem ipsum dolor sit amet, consetetur sadipscing elitr, sed diam nonumy eirmod tempor invidunt ut labore et dolore magna aliquyam erat, sed diam voluptua. At vero eos et accusam et justo duo dolores et ea rebum. Stet clita kasd gubergren, no sea takimata sanctus est Lorem ipsum dolor sit amet. Lorem ipsum dolor sit amet, consetetur sadipscing elitr, sed diam nonumy eirmod tempor invidunt ut labore et dolore magna aliquyam erat, sed diam voluptua. At vero eos et accusam et justo duo dolores et ea rebum. Stet clita kasd gubergren, no sea takimata sanctus est Lorem ipsum dolor sit amet.
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"Especially in the area of quality, FOBA fulfills our needs better than many other providers. In close cooperation with FOBA's laser marking experts, we set up the appropriate technical environment that allows us to comply with the high implementation requirements of UDI-marking on medical instruments. For us, the camera based marking validation being integrated in our production process is essential."
Nermin Duratovic, CEO - add'n solutions GmbH & Co. KG
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