Hi all,
I'm new to medical device regulatory affairs and recently joined a team developing medical device. During an ISO13485 audit we were told that we have no evidence of software development in compliance with IEC62304. However, we're already half way into the software development process (have alpha version tested). Is there a way to implement IEC62304 into the development at midpoint? or we have start over with a software development plan that's in compliance with IEC62304 from scratch?
Also, is IEC62304 mandatory or de-facto mandatory in order to be ISO13485 certified?
Any advice would greatly appreciated. Thank you!
I'm new to medical device regulatory affairs and recently joined a team developing medical device. During an ISO13485 audit we were told that we have no evidence of software development in compliance with IEC62304. However, we're already half way into the software development process (have alpha version tested). Is there a way to implement IEC62304 into the development at midpoint? or we have start over with a software development plan that's in compliance with IEC62304 from scratch?
Also, is IEC62304 mandatory or de-facto mandatory in order to be ISO13485 certified?
Any advice would greatly appreciated. Thank you!