EU MDR general safety and performance requirements (GSPR) checklist

 

Meet the EU MDR's general safety and performance requirements for your medical device.

 

Download our EU MDR general safety and performance requirements (GSPR) checklist to:

 

  • Understand every requirement your business and device(s) must follow for EU-compliant medical device safety and performance 

  • Take controlled step-by-step action to get compliant

  • Pinpoint gaps in your medical device quality management system and satisfy your EU notified body inspector

 

Complete the form to the right to get started!

 

What you'll get:

 

  • Subttasks-bg4-part XLSX checklist

Access a comprehensive and ordered Excel checklist to work your way through your GSPR demands

 

  • Lightning circle-bgItemized action points
From referencing documents in your Design History File (DHF) to ticking off device requirements, work your way through the checklist to plug gaps and maximize compliance



  • Setting-bgAnnex-specific requirements list
Understand the requirements by annex and chapter and build a comprehensive record of documentation to prove compliance to your inspector