•	Regulatory Consulting Services

MediTech provides a complete guidance for our clients according to the relevant European Directives including:

 

	Clinical Investigations
	Medical Device Classification
	Conformity Management Procedures
	Medical Device Vigilance Reporting
	Quality Assurance Systems
	ISO Certification
	Quality Audits
	Essential Requirements
	Labeling / Instructions for Use (IFU)
	Technical Files
	CE Mark Guidance
	Risk Analysis
	Declarations of Conformity
	Liaison for Notified Bodies, Competend Authorities & the EU Commission

 

 

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