Supplier requirements - Major supplier is a Non-Profit registered with ICCBBA (FDA UDI)

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
M E M O R A N D U M

To:

From:

cc: N/A

Date:

RE: Justification for Supplier Approval Outside standard SOPs (or something like this)

Purpose:

The purpose of this memo is to document the benefits of using this supplier despite not adhering to established predicate standards defined for other suppliers....

Background:

<A background on how you got here and what the history is>

References:

· Risk Management SOP-RISK-001

FDA QSR Reference

· Traceability Matrix, list your documents here

· Design and Development Plan for devices # # #

· ISO 14971:2019 Medical devices – Application of risk management to medical devices.

Methods:

· Test Reports, literature review, etc.

The official opinion of an expert in this subject matter.

That persons resume cv

Justification:

During the design process of your product name, one of the product requirements was that <Explain why this supplier is unique to provide the parts/service to meet customer requirements.>

Explain the risk of not using your normal SOP

Explain how you will mitigate that risk

Explain the duration of time this memo will serve


Conclusion:

Why this is acceptable.
 

MDRexpert

Involved In Discussions
Can someone tell me what they are doing specific to GS1?
I am wondering if this is just our company or other people have had similar issue?
 
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