Medical device registration in Europe requires CE Mark certification. Although not an easy process, obtaining CE Marking for your medical device offers access to all member countries that belong to the European Union.
In this podcast, Emergo Managing Director for Europe Colin Rylett provides an overview of key steps necessary to obtain CE Marking to commercialize your medical device in Europe. Major points of discussion include:
- The role of Medical Device Directives in the CE Marking process
- Classification of medical devices in Europe
- Technical File requirements and components
- ISO 13485 and quality system requirements
- The role of Notified Bodies in CE Mark certification and quality system auditing
- Post-market requirements
Additional resources on European CE Marking available from Emergo include an EU regulatory process chart, a video overview of the CE Mark process and a whitepaper on Notified Body audits.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.
The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.
The post Emergo Podcast: CE Marking for medical devices in Europe appeared first on MassDevice.
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