ISO 13485 & EU MDR / 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
Please select user.
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
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:
HTML tags are not allowed