About
Medra+ is a Regulatory Affairs, QA and Clinical Affairs consultancy firm, with proven expertise and skills for the last 20 years in the field of Global Regulatory Affairs of medical devices, IVD's, drugs & pharmaceutical products and cosmetics. We assist in Design & Development, ISO 13485, QMS Compliance, Technical file writing including CER writing, 510k submissions, CE (MDR/IVDR) approval arrangement and Asia registrations. Our goal is to help our clients to achieve their sales in a very cost-effective way by integrating and understanding of international regulatory requirements. We are specialized in QA, Regulatory Strategy and Clinical Affairs consultancy.
Technologies
Gmail
Google Apps
Mobile Friendly
Google Font API
Woo Commerce
WordPress.org
Google Tag Manager
Stamped
AI
Keywords
iso 13485
risk management
design & development
medical device software documentation
ivdr
mdr
mda malaysia
product registration
training
cer
ce
clinical trial
validation
qms implementation & audit
gmp
medical device
hsa
usability
software validation
technical file
clinical evaluation report
510k
cro
medical writing
gspr
medical equipment manufacturing
regulatory audit support
regulatory consulting
regulatory documentation
medical device regulatory
Company Information
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Employees 5
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Founded 2015
Location
10 Ubi Cres, Singapore, Singapore, Singapore, 408564
