MDSAP Phase 2

[Ed Panek]

Hypothetical Scenario

A US-based medical device OEM has one Medical device (Product A) as Class II under FDA and IIa under MDD/MDR. The 13485 and MDSAP scope is limited to this device design & manufacture.

This company also develops a non-medical device (Product B) that can utilize the output of the (Product A) medical device. Product B is not considered a medical device because of how it's used, though.

For customer peace of mind Product A and now B both live inside the OEM 13485 QMS under separate design files.

This OEM recently released a change in a single change notice referencing both devices as some changes to User Interfaces were identical. The documents for Product A&B are moved to their respective design files.

During an Audit, a list of changes is requested. This change is needed for review.

The Auditor sees the details of the CN and notes Product B as well. They inquire about it.

How would you respond? Out of scope? Non-medical device?

I'd prefer a single reason and not multiple.

 

[Nichole F]

I've encountered similar situations at previous companies I have worked for. Usually the auditor is satisfied if you tell them Product B is not a medical device. Some may ask why and I would just explain how Product B works or is used. If not obvious from that explanation, further consideration as to why it is not considered a medical device may be needed but from my experience 90% of auditors will be perfectly happy with "it's not a medical device".

 

[ChrisM]

What is the scope of the audit, and is it first, second or third party?

 

[Ed Panek]

Scope is MDSAP for product A only. Its nb audit

 

[ChrisM]

Ah - in which case it depends on the depth of their enquiry. I'm trying to think of this as a parallel situation to where I once worked except both products were medical devices. In theory in your case, I would suspect that there could be a case of replying "out of scope" but maybe for document control and design history purposes, the assessor wanted to see how you handled this situation - who makes the assessment regarding what needs to be done for product B etc. I'd be tempted to play along with the assessor initially, rather than immediately suggesting he was going too far in case he may think you are trying to cover something up.