Implementing Risk Management in a Medical Device "Distributor Only" company

Aphel

Involved In Discussions
#1
Hello!

I would need a recommendation for how to implement risk management in a medical device "distributor only" company?

We want to certify our company acc. ISO 13485; we have no R&D and no production, we act only as distributor for other legel manufacturers in the company group.
The auditor who will come and conduct the audit has requested (beside other general procedures) our risk management procedure in advance!?

The issue now is - a distributor company cannot implement a risk procedure according ISO 14971 from point of view... am I wrong?
We only have the idea to implement FMEA in order to evaluate our internal processes like storage & distribution - to identify possible impacts on devices we handle. Is this enough???

Thanks a lot for your comments/help in advance!

BR
Aphel
 
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somashekar

Staff member
Super Moderator
#2
Re: Recommendation for risk management

First, ISO 14971 is not mandatory for the risk management. Its a note 3 to see for guidance in the ISO 13485.
You should be OK with FMEA for the processes in your scope.
Consider things that can effect the device in terms of storage and transport conditions, which in turn can directly effect the user / patient. Get information from the device manufacturer about these which are essential for you to know, and these can be present in the device information for use, or in other technical information that is available with the manufacturer. Know them and consider them in your risk management documentation, and decide your such effective control measures.
 

pkost

Trusted Information Resource
#3
Re: Recommendation for risk management

ISO 14971 is intended for manufacturers, not distributors. The standard is about risk for the health and safety of the patient - this has already been investigated by the manufacturer. All you have to do is follow their instructions

Your business needs to consider your business risk. Consider the following...risk: product may not be suitable for storage in hot conditions

A manufactuerer (and ISO14971) cares that this will lead to an ineffective device that harms the patient
As a distributor you care that you have stock that is non conforming and needs to be written off

This is not to say you can't use concepts from 14971, just that it isn't entirely appropriate
 
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