Medical device regulations across the globe – a headache for Service Engineers?
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Medical device regulations across the globe – a headache for Service Engineers?
Are there still differences in Medical/pharmaceutical equipment regulations across the globe that have an impact on how Field Engineers have to work in different countries?
Is it more challenging in some countries than others?
Could you offer some advice to newcomers to the role on what to be careful about in different countries when servicing medical equipment in regard to any differences in regulations? Or maybe “unwritten rules” that are followed in different countries?
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5 Replies
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I never work outside of my country, but in Brazil, in the aspect of the Field Enginners i don’t think there are any special requirement. But for the company that this field enginner is working for there is many, some certifications, mostly ISO9001, ISO17025 and some certifications of the regulatory agency (in the case ANVISA)
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Thanks for the reply Luigi.
When I asked the question I had not considered that there are two types of certification, one for the company itself, and also one for the engineer(s) who perform(s) the service/support job.
I’m sure there must be situations where engineers are sent in to service products in countries where their certification is not valid, or they are not aware that it is not valid.
Do service departments have to keep records of all of the service certifications their service engineers have?
If so how do they do this?
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It depends in the laws of the country, probably if different in UK, USA, etc.
But as far as i know, usually if the certification is from a known source, here in Brazil is accept as a valid certification.
When in needed the company usually has a internal system to keep who has the certification, probably that company has to have ISO9001 so you will have a spreadsheet in a version controlled system, or the company have some internal program to do so, the ISO9001 don’t say how to do, just you need to do somehow.
If the company doesn’t have the ISO9001 certification, they can make a simple spreadsheet, i’m not aware of any laws here in Brazil that specify this kind of thing. Maybe with the LGPD (Data Privacy Regulations of Brazil) this can change, but i’m not sure at this point.
I’m not aware about the laws of other countries, so i can’t say properly if it’s right for other countries.
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In the US OEM’s have filed lawsuits against 3rd party service providers but these have for the most part been struck down. I know one OEM in the histology sector that doesn’t really have a Field service force and almost completely relies on 3rd party people that they train.
OEM’s generally will not let an FSE lay hands on a piece of equipment they have not beeen formally trained on in the medical sector, in some others this is not the case.
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Thanks for this Carl, very interesting.
(Apologies for the delay in replying to you).
Tim
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