Supplier controls for consumer-grade off-the-shelf products

[Jon S]

Hello - I'm currently working on supplier evaluation and qualification for a medical device software company. All supplied products are off-the-shelf and/or available to the general public, such as cloud and web services, PC hardware, etc.

Am I required to monitor such suppliers (e.g. Dell, Amazon, etc.) with the same types of qualifications and controls as raw material or custom component suppliers? I understand I need the processes in place for both 820.50 and 13485 Sec. 7.4, but I'm more familiar with the processes and controls for hardware materials and components.

Thanks!

 

[shimonv]

Hi Jon,
The first question to ask is what is the classification of this supplier? i.e. critical or not.

I assume it is not critical because most probably you do in-house software V&V and have relevant production controls. If I'm correct, you could apply basic controls in accordance with your Purchasing Controls procedure; by 'basic' I mean things a questionnaire and ISO 9001 certificate.

-Shimon