Hi,
Do you think there is sense to certify subsidiaires of a medical device manufacturer according to ISO 13485 ?
I think there is if the scope is limited to the activities contractually delegated by the manufacturer (sales, installation, service,..) and operated usually by the subsidiaries.
What is your opinion ? Is this a burden of work for a subsidiary ?
Th.

When you refer as subsidiary, is that a manufacturing site ?

By 'subsidiaries', I mean sales & services organizations whose activities are selling, installing, training, servicing customers.
Th.

I think it makes sense. There are plenty of medical device sales and service companies that are 13485 registered. It shows they have proper processes for incident reporting, advisory notices, recalls and handling.

I do not believe it is a requirement for subsidiaries that are doing sales, installation and training to be registered to ISO 13485.
Some do it because of corporate policy and because they may handle the regulatory issues of the country that they are selling.

Danny

You're right Danny, although if the subsidiary has the same name as the main company - the one whose name is on the product it may be an issue, in Canada anyway. But I'm not as familiar with the European regulations.

It is indeed our thoughts. You say 'plenty'...could you name some examples of manufacturers that imposed that to their subsidiaries because I do not know such examples in EU. Tx

I was referring to independent sales and servicing medical companies that obtain 13485 registration as a competitive advantage - perhaps plenty was a bit of an overstatement now that I actually looked them up :o
In any case I doubt it was imposed by the manufacturer but may alternatively have come about to enable some repackaging or reprocessing not to the original manufacturer's spec.

I know that Philips in Canada is ISo 13485 approved but does no manufacturing from the site.