Regulatory Affairs for Medical Devices – EU MDR and IVDR
Regulatory Intelligence
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Tools and Services
Features for success
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RA Assistant
Your Professional Partner
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Regulatory Affairs Assitant – Elly
TEST ELLY NOW
GLOBAL REGULATORY
KNOW-HOW
AT YOUR FINGERTIPS
What are the main Use-Cases of Elly:
- Up to date on Regulations and Guidelines of 35+ Countries
- Communicate with 1000’s of regulatory-related documents
- Create Initial Regulatory Assessments with One Click
- Get Assistance in creating the Intended Purpose
- Get Assistance in classifying the product under EU MDR/IVDR and FDA
IT INCLUDES: Complete MDR, Complete IVDR, New published EU documents, MDR / IVDR implementation guide