About
Kobridge Consulting assists medical device companies in obtaining CE Marking, implement ISO 13485 or GMP quality systems, submit applications to access to different markets: USA, Europe, Canada... The mission of Kobridge Consulting is to assist companies with most international quality and regulatory compliance issues, or if needed to outsource Regulatory Affairs and Quality Assurance (RA/QA).
Technologies
SendInBlue
Gmail
Google Apps
Microsoft Office 365
Mobile Friendly
Google Font API
WordPress.org
Google Tag Manager
Viewpoint
Data Analytics
Remote
Box
AI
Reviews
Keywords
regulatory affairs
quality
medical devices
korean medical device regulation
medical equipment manufacturing
regulatory gap analysis
fda clearance
software validation
product registration support
eu mdr harmonized standards
regulatory consulting
b2b
medical device regulations
ivdr
clinical evaluation reports
iso 14971
internal audits
software lifecycle compliance
iso 9001
data management
ce marking
iso 13485
global market submissions
medical device registration
mdsap
medical device standards
regulatory process optimization
eu mdr udi requirements
technical documentation
eu mdr
Company Information
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Employees 1
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Founded 2007
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Annual Revenue $506000
Location
2 Rue Caroline, Lausanne, Vaud, Switzerland, 1003
