A Playbook for Successful Revision and Implementation
The release of the European Medical Devices Regulation (EU-MDR) has put significant pressure on medical device companies to closely scrutinize the new regulations, assess the impact on their own organization, and implement compliant processes and procedures accordingly.
This white paper presents key regulatory changes and a clear and concise process for structuring your transition process no matter how far along your organization is.
What you'll find inside:
• A brief overview of the basics of the EU-MDR, focusing specifically on key changes
• A strategy for planning and scoping your EU-MDR transition program
• How to conduct a thorough gap analysis specific to EU-MDR transition
• How to scale your transition program to encompass the entire enterprise
• The key steps of implementing an EU-MDR transition program
• Timeline considerations
• And much more
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