EU MDR Kit

EU MDR Technical Documentation Kit

EU MDR Technical Documentation Kit provides a broad range of technical documentation templates ready to be used for your Regulatory Submission.

249 €

Topic	Procedure Title
EU MDR Specific Templates	GSPR Checklist for EU MDR 2017/745
	Declaration of Conformity Template
	Requirements Checklist for Technical Documentation According to EU MDR 2017/745
	Strategy for Regulatory Compliance Procedure
	PRRC Designation Letter Template

Post Market Surveillance	Post-market Surveillance Template
	Periodic Safety Update Report Template
	Post-market Surveillance Report Template

Risk Management Process	Risk Management Procedure
	Risk Management Plan Template Risk Management Report Template Risk Analysis Template Hazard Analysis Template Traceability Matrix Template

Usability	Usability File Template
	ISO 62366 USability Requirements Checklist

Biocompatibility	Biological Risk Assessment Template

Labelling	ISO 20417 Compliance Checklist

Change Management Process	Change Control Procedure Notified Body Change Notification Procedure

Clinical Process	Clinical Development Plan Template Clinical Evaluation Plan Template Investigatore Brochure Template

Take a look to the EU MDR Technical Documentation Kit and speed-up the preparation of your EU MDR Submission

249 €