•	CE Mark Guidance

In order to obtain the CE mark for your medical device products, MediTech offers our complete guidance on medical device classification according to the relevant European Directives, including conformity assessment procedures.

 

We also can provide support in preparing the CE submission dossier including:

	Essential Requirements Checklist
	Design File
	Technical File
	Clinical Data Evaluation
	Labeling / Instructions for Use (IFU)
	Quality Management Systems Audits
	Risk Analysis
	Medical Device Vigilance Reporting
	Liaison for Notified Bodies, CA en EU Commissions
	Declarations of Confirmity

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