About
QARA Consulting AB is based in Helsingborg and Stockholm. We are senior and expert consultants supporting clients within the medical device industry. We offer a complete range of multidisciplinary quality and regulatory services from initial device classification, technical file writing, clinical evaluations to post-market surveillance. Over the years, has our team conducted several large assignments and established partnership with clients, industry and associations.
Technologies
Outlook
Microsoft Office 365
Vimeo
Mobile Friendly
Varnish
Google Tag Manager
Google Analytics
Apache
Remote
Keywords
medical equipment manufacturing
sterilization methods
post-market surveillance
risk management
external test setups
software validation
regulatory compliance
gmp production
project management
mdr 2017/745
technical file writing
iso 14971
b2b
cleanroom validation
clinical support
training services
ce certification
iso 13485
cybersecurity for medical software
iso 14155
other scientific and technical consulting services
clinical evaluation
cybersecurity
audit support
device classification
validation protocols
regulatory submissions
consulting
clinical investigation documentation
healthcare
Company Information
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Employees 1
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Founded 2004
Location
27 Drottninggatan, Helsingborg, Skane County, Sweden, 252 21