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Luigi Filho replied to the discussion Medical device regulations across the globe – a headache for Service Engineers? in the forum Medical, pharmaceuticals, life science, bioscience 4 years ago
Medical device regulations across the globe - a headache for Service Engineers?
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…
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Tim Robertson replied to the discussion Medical device regulations across the globe – a headache for Service Engineers? in the forum Medical, pharmaceuticals, life science, bioscience 4 years ago
Medical device regulations across the globe - a headache for Service Engineers?
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…
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Luigi Filho replied to the discussion Medical device regulations across the globe – a headache for Service Engineers? in the forum Medical, pharmaceuticals, life science, bioscience 4 years ago
Medical device regulations across the globe - a headache for Service Engineers?
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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Varun Sharma posted an update in the group
Medical, pharmaceuticals, life science, bioscience 4 years agoHello folks,
I have been working on X-rays from last 10 years with different combinations likes cathlabs, ct scans, xrays (dr.conventional) drf’s etc… is anyone in this group working on the same.. let’s discuss
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