Expert Advice Community

Guest

Most efficient steps in regulatory pathway to introduce class III implantable device

  Quote
Guest
Guest user Created:   Mar 24, 2022 Last commented:   Mar 28, 2022

Most efficient steps in regulatory pathway to introduce class III implantable device

in order to introduce a class III implantable device manufactured in our own startup company, what is the most efficient steps in the regulatory pathway you would you advise? Eg Establish QMS - compile dossier of pre-clinical evidience - seek regulator approval for phase I safety trial - CE mark product - ISO13485 certification?
0 0

Assign topic to the user

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

Expert
Kristina Zvonar Brkić Mar 28, 2022

Please consider the following steps: 
Establish QMS - compile a dossier of pre-clinical evidence -  seek regulator approval for phase I safety trial - prepare the technical documentation - CE mark product and ISO13485 certification (last two steps goes together).

Quote
0 0

Comment as guest or Sign in

HTML tags are not allowed

Mar 24, 2022

Mar 28, 2022

Suggested Topics

Vilmona Created:   Apr 05, 2024 ISO 13485 & EU MDR
Replies: 3
0 0

Repackaging of a medical device

Guest user Created:   Jun 12, 2023 ISO 13485 & EU MDR
Replies: 1
0 0

MDR classification