Orange-Moon

Orange-Moon

MDR / IVDR compliance efficiently

MDR & IVDR Compliance Service for Medical Devices / QMS Outsourcing

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EU Authorised Representative Pitfalls
The MDR has implemented quite some surprises for medical device manufacturers who are not established in the EU. They need an authorised (authorized in American...
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MDR in sudden force: Brexit decision about to export for British MD companies.
EU Withdrawal Bill clears House of Commons - and is about to nuke MD companies (Photo by frankieleon https://www.flickr.com/photos/armydre2008. Licensed under Creative Commons License https://creativecommons.org/licenses/by/2.0/legalcode.)...
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Artificial Intelligence Expert
Bringing artificial intelligence into regulatory environment This position is about cooperating with the entire technical team to build a world class system for regulatory affairs....
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Lead Internal Quality Management
Be the head of our internal quality assurance Implementation and maintenance of our internal QMS Preparation and conducting of employee training Reporting to management Documentation...
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