Regulatory Concepts

Regulatory Concepts for the healthcare industry

MT Promedt Consulting provides competent and professional support to achieve regulatory compliance for innovative products worldwide. Our consultation guides through the complexities of the European and US FDA as well as international regulations. From product development to marketing we provide 'hands-on' assistance in order to gain fast implementation of applicable legal requirements and to attain CE certification and international approvals in a cost effective manner and within a clear period of time.

The services routinely provided include

	Regulatory Due Diligence
	Strategies for CE Conformity Assessment Procedures
	International Product Registration
	Product Safety Testing Strategies
	Expert Reporting for Extractables/Leachables and Biocompatibility
	Clinical Research Services
	Reimbursement strategies

MT Promedt Consulting has proven expertise in a wide range of different medical devices and IVD including

	Biodegradable devices
	Active Medical Devices
	Combination Products/Consultation Procedures
	Devices with Animal Tissue

In order to discuss your specific needs please feel free to contact us.