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

ISO 13485 & EU MDR
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Guest user Created:   Mar 24, 2022 Last commented:   Mar 28, 2022

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

ISO 13485 & EU MDR
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?
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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.
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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).

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Mar 28, 2022

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