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MHRA & Med Devices RO requirement after Jan 1 2021

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Guest user Created:   Oct 14, 2020 Last commented:   Oct 15, 2020

MHRA & Med Devices RO requirement after Jan 1 2021

hi, Kristina what services are you providing for the new regulations and Med device RP requirements post Brexit for imported Medical Devices? thanks
 

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Oct 15, 2020

If by RP you mean Responsible person as is defined in MDR 2017/745  Article 15 and  Article 16, Advisera can offer you the following documentation templates that cover the post-market surveillance system:

In the Procedure for Post-Market Surveillance System is described who can be and what are the responsibilities of the Person for regulatory requirements.

For more information, see:

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Oct 14, 2020

Oct 15, 2020