Outsourced Processes Control (Finished Medical Device Delivery, Storage)

[Aliasanonymous]

Hi!

I've looked searched through the threads and nothing quite answers my query.. kindly point me to it if there is!

The company I'm working for is doing distribution for medical devices and is looking to outsource our storage and delivery process.. suppliers would deliver products (finished medical devices) to the outsourced storage, and the goods would be delivered to the customers directly from there.

That said, we would not have direct contact with the products, and hence I'm guessing Inspections would be considered outsourced too.

My question is, what kind of control would be required for these processes, and how should it be mentioned in the QMS documents.
Also, is there a need for risk management (FMEA and whatnot) for these outsourced processes?
Any advises or examples would be much appreciated.

Thank you!

 

[Ronen E]

Hi!

I've looked searched through the threads and nothing quite answers my query.. kindly point me to it if there is!

The company I'm working for is doing distribution for medical devices and is looking to outsource our storage and delivery process.. suppliers would deliver products (finished medical devices) to the outsourced storage, and the goods would be delivered to the customers directly from there.

That said, we would not have direct contact with the products, and hence I'm guessing Inspections would be considered outsourced too.

My question is, what kind of control would be required for these processes, and how should it be mentioned in the QMS documents.
Also, is there a need for risk management (FMEA and whatnot) for these outsourced processes?
Any advises or examples would be much appreciated.

Thank you!

Hi,

A few clarification questions:

1) What sort of devices are these?
2) In what country / region are you located?
3) In what country / region will the warehouse / distribution center be located?
4) Into what country / region will the devices be sold?
5) Will the storage / distribution center entity take (commercial) ownership of the devices, or just provide you a service for a fee?

Cheers,
Ronen.

 

[Aliasanonymous]

Thank you for your reply.

1) What sort of devices are these?
we are actually looking at a wide range of devices, from IVDs to cardiovascular implants etc. In what way would this affect the controls?

2) In what country / region are you located?
Singapore

3) In what country / region will the warehouse / distribution center be located?
Singapore

4) Into what country / region will the devices be sold?
Singapore and other SEA countries (Malaysia, Indonesia etc)

5) Will the storage / distribution center entity take (commercial) ownership of the devices, or just provide you a service for a fee?
They would just provide us the service for a fee.

Thank you!

 

[Ronen E]

Thank you for your reply.

1) What sort of devices are these?
we are actually looking at a wide range of devices, from IVDs to cardiovascular implants etc. In what way would this affect the controls?

2) In what country / region are you located?
Singapore

3) In what country / region will the warehouse / distribution center be located?
Singapore

4) Into what country / region will the devices be sold?
Singapore and other SEA countries (Malaysia, Indonesia etc)

5) Will the storage / distribution center entity take (commercial) ownership of the devices, or just provide you a service for a fee?
They would just provide us the service for a fee.

Thank you!

Thanks for the additional information, now you have better chances to get useful answers...

The type of devices determines (in most advanced regulatory systems) the devices classification, which in turn determines the required controls.

Are the devices in question going to bear your name on their labeling ("private label" / "own brand label"), or will you be simply buying other companies' devices, having them shipped into the distribution center in Singapore, and then fulfilling customers orders?

Once the above are addressed, it should be fairly simple to follow the Singapore regulations and determine what sort of controls should be implemented (and in general, what should be done).

For sales into other countries (Malaysia, Indonesia etc.), their own regulations must be observed to ensure that you'd be complying; However, AFAIK Singapore's system is the most comprehensive / advanced in that region, so you're likely to be OK if you comply with the Singaporean system.

Cheers,
Ronen.

 

[Aliasanonymous]

Yes, we're simply buying and distributing.

We're looking to comply to the ISO 13485 standard because we're going for that certification soon. (audit's the end of this month!:mg
So I'm seeking answers with regards to the ISO standard.

Thank you!

 

[Aliasanonymous]

Oh, and if it's of any use.. the devices are in the class IIb or III according to the EN MDD.

 

[harry]

Are you aware of your own country's Good Distribution Practice for Medical Devices?

 

[Aliasanonymous]

Harry,

Yes, I am aware. But like I mentioned, we're looking to comply with ISO 13485 as we're going for that certification.

 

[Ronen E]

we're looking to comply with ISO 13485 as we're going for that certification.

Sounds like a strange choice to me. ISO 13485 is intended for manufacturers of finished medical devices. Your company doesn't make the devices; it's not bearing label responsibility; and you're actually looking to also outsource the tail end of the distribution chain. What's left? Commercial processing and importation into Singapore? Regulatory affairs?

It's not that ISO 13485 is impossible to implement in your case, it's just that you'll probably find yourself excluding so much, to a point that you could have simply implemented ISO 900_ or Singapore's GDPMD.

 

[Aliasanonymous]

Oh. We're also doing R&D for medical devices we would manufacture in future, but that's in future. So looking ahead, we decided to go for ISO 13485 and expand the scope to include design and manufacturing, when that's ready, instead of GDPMDS.
Wise decision or not, it's sealed. So any help I can get now would be much appreciated.

Thank you!