Yes exactly! The team had this box ticked and given the date of certification I’m sure that we were in compliance with the changes of the regulatory standard ISO13485:2016 being implemented in 2019. As previously mentioned, a possible delay with our CE green light is the increased workload the notified bodies have received this year due to this ISO change. My understanding is that all companies applying or current need to comply.
Keep up the great posts Red Bar!
The world awaits ResAppDx
Dave
