Device Master Record Vigilance

R

Renea Koski QSM

Starting to get Involved
#1
#1
If we are excluding Design 7.3 (ISO 13485:2016) (We are only the contract manufacturer,) do we need Device Master Records and Risk Management Analysis for product families?
Also we are not pursuing MDR either. Just ISO 13485:2016 and FDA 21 820, is a Vigilance Procedure necessary?
 
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Y

yodon

Leader
Super Moderator
#3
#3
Pending your response to the insightful question @indubioush raised...

I think it's generally most efficient for the CM to manage the DMR.

I don't believe you'll need a Vigilance Procedure.

I would suggest you DO have risk management procedures but scoped to what you will do. It's important you understand what your role in RM is and what your customers' role is. Your customers have to define the acceptability policies. Your responsibility will likely be limited to a Process FMEA and that should align with your customers' policies.
 
R

Renea Koski QSM

Starting to get Involved
#4
#4
We are manufacturing a final device with our customer's name on them. They hold the FDA 401K and the technical design files. I do have a risk procedure with a plan and analysis for each product family, (we make surgical instruments.)
In all the previous audits, (I am new here and the QMS is kinda a mess . . ) there were exclusions to Design and Development, but no mention of DMRs by the auditors. No mention of the risk files either . . .but I knew we needed those. Could be because the QMS was sooooo terrible, the auditors just kept it to the stuff we need, and we do not do design.
I wasn't sure about Vigilance because at my previous employer, we were going for MDR, but here we are not. But still wasn't sure if that was just a MDR-EU thing.
 
I

indubioush

Ah ha!
#6
#6
This needs to be a discussion with your customer. You need to develop a very clear quality agreement outlining what you are responsible for and what they are responsible for. If needed, you should have a process for managing shared documentation and for performing change control activities.
 
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