(+86)-400-6768632

(+49)-30-81865123

global@osmundacn.com

Home > Service > PRRC
PRRC


According to European Regulations on Medical Devices and in vitro diagnostic medical devices, manufacturers shall have available at least one person responsible for regulatory compliance who possess demonstrated expertise in the field of medical devices. 


The Person Responsible for Regulatory Compliance (PRRC) shall be at least responsible for ensuring that:

a)Conformity of devices are appropriated with the relevant Quality Management System (QMS) 

b)The technical documentation and EU DoC are up-to date

c)Post market surveillance obligations are properly performed 

d)Reporting obligation on  serious incidents and field safety corrective actions are met


Manufacturers would be wise to hire this position with qualified professionals to:

1.Be compliant with the EU regulatory requirements

2.Ensure the safety and compliance of the marketed devices

3.Avoid any financial penalties or reputational harm


If you need a PRRC, Contact us to know what Osmunda can do for you!


Company Profile
Our services
Contact us
+49 30 5059 0627+49 30 8186 5124
email:osmunda@osmundacn.comglobal@osmundacn.com
LinkedInOsmunda
Copyright © 2023 Osmunda Medical Device Service Group              粤ICP备05082100号-3