Should we have risk management procedure including FMEA for all product lifecycle?
We bought the toolkit MDR/ISO13485 and have the following question:
If we are a manufacturer (specification holder) and we have contract manufacturer for all our products (so practically we outsource design and development and all manufacturing stages but we only do sales activities for products under our brand name/trademark), should we have a risk management procedure including an FMEA for all the product lifecycle? Or we only make a quality agreement with the manufacturer (OEM) which includes all the requirements and we supervise implementation?
A note all our contract manufacturers are MDR Compliant and ISO 13485 Certified.
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ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more 
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
You can make a Risk analysis for your part of the life cycle (sales and storage??) but then claimed that other parts of the risk analysis are within a particular outsourced company. To allow your awareness of this, you need to have an exact number of documents and revisions of the risk analysis from your outsourced companies, and during your audits of the outsourced companies you need to audit their risk analysis as well.
All of this is of course part of the Quality agreement. Just have in mind that no meter that you outsource everything, you are responsible for the product because it is under your name. So, you need to have control over all processes.
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Apr 24, 2023