About
NEXTEC medical GmbH is an EN ISO 13485:2016 certified company. With over 25 years of experience in medical device regulatory affairs, we are your trusted partner of choice when it comes to acting as Legal Manufacturer or European Authorised Representative as well as Contract Developer for Medical Device Software with or without the use of Artificial Intelligence.
Technologies
Outlook
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Keywords
medical devices
ivd
diga
dipa
dtx
medical equipment manufacturing
ai in medical device software development
medical device regulatory affairs
medical device software with ai
regulatory affairs experts
medical device regulatory compliance
regulatory documentation transfer
ec rep service
european medical device regulations
regulatory strategy for medical devices
medical device software lifecycle
mdr 2017/745
european authorised representative
medical device documentation
artificial intelligence in medical devices
legal manufacturer service
regulatory affairs consulting
medical equipment and supplies manufacturing
european market access
ai-enabled medical software development
medical device certification
regulatory support for medical device software
consulting
medical device software for internal processes
en iso 13485:2016
Company Information
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Employees 4
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Founded 2018
Location
Badenweiler, Baden-Wuerttemberg, Germany
