About
MDRA Solutions provides regulatory affairs consulting to medical device and IVD companies mainly focused on the international markets such as LATAM, APAC, ASEAN, and EMEA. We assist with medical device registration/approval, renewals, change notifications and regulatory strategy. Also, we help with EU MDR STED and technical file/design dossier development, maintenance and remediation. For more information, email [email protected]
Technologies
Outlook
Microsoft Office 365
reCAPTCHA
Google Analytics
Mobile Friendly
Weebly
Keywords
medical device
international regulatory affairs
design dossier
technical files
regulatory assistance
medical device & ivd registation
regulatory affairs submission strategy & compliance
dossier review
preparation & submission
global regulatory affairs
international regulatory registrations
regulatory affairs education
regulatory consulting
first-time device registration
regulatory intelligence platform
regulatory affairs
consulting
eu mdr 2017/745
project management
design dossier remediation
regulatory compliance strategies
regulatory project management
testing laboratories and services
regulatory standards
international regulatory services
regulatory intelligence research
regulatory process improvement
eu mdr
regulatory gap analysis
b2b
Company Information
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Employees 1
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Founded 2019
Location
Canada Pl, Vancouver, British Columbia, Canada, V6C
