We are Medical Device Software company in US with ISO 13485 certification and currently in process of getting our CE Mark for our Class IIa PACS Device.
We just went through a MDD /Technical File gap audit and are awaiting our MDD expansion audit with TUV-SUD.
Our other 2 devices are Class 1 low risk devices (MDDS & Intra-Oral Camera) which are only sold in US.
I am updating all our QMS docs for our other 2 products and have a couple questions on how to state or what is required for non-applicable activities, processes, and procedures.
1. Do we need to create any Technical Documentation for these other devices?
2. How do we state in our Procedures and/or Plans IE: Post Market Surveillance Procedure and Plan, Clinical Evaluation Plan… that certain activities are N/A?
I am new to Regulatory so any feedback is greatly appreciated.
We just went through a MDD /Technical File gap audit and are awaiting our MDD expansion audit with TUV-SUD.
Our other 2 devices are Class 1 low risk devices (MDDS & Intra-Oral Camera) which are only sold in US.
I am updating all our QMS docs for our other 2 products and have a couple questions on how to state or what is required for non-applicable activities, processes, and procedures.
1. Do we need to create any Technical Documentation for these other devices?
2. How do we state in our Procedures and/or Plans IE: Post Market Surveillance Procedure and Plan, Clinical Evaluation Plan… that certain activities are N/A?
I am new to Regulatory so any feedback is greatly appreciated.