Hi to all
I'm working in a new project that will lead to a Class I medical device Certification. In our plan of activities we have placed the following steps inside risk management:
We also conceived to subcontract this activities (it is out of our expertise) to a CRO (contract research organization). Do any of you have an idea of reasonable costs for these kind of documents?
Cheers
BMAFG
I'm working in a new project that will lead to a Class I medical device Certification. In our plan of activities we have placed the following steps inside risk management:
1. Risk Management Framework
Considering that it will be only one person dedicated to this, can you please help me defining a reasonable number of hours to dedicate to these tasks.a) Risk Management Report
b) Device Characteristics
c) Risk Analysis
b) Device Characteristics
c) Risk Analysis
We also conceived to subcontract this activities (it is out of our expertise) to a CRO (contract research organization). Do any of you have an idea of reasonable costs for these kind of documents?
Cheers
BMAFG