About
'- Consultancy in the areas of biocompatibility according to ISO 10993, FDA Guidance Document, ISO 14971, MDR, ISO 13485 -Consultancy in the particulate testing of medical device according to USP 788, AAMI TIR 42 -risk management support according to ISO 14971
Technologies
Outlook
Microsoft Office 365
Google Tag Manager
WordPress.org
Google Font API
Mobile Friendly
Remote
Keywords
particulate testing
rohs
mdr
reach
biocompatibility
aami tir 42
iso 14971
iso 13485
echa
iso 10993
usp 788
fda guidance document
risk management
medical equipment manufacturing
biocompatibility report
particle testing
particle contamination control
toxicological risk assessment
healthcare
literature research
gap assessment
consulting
regulatory submission support
material safety
device design evaluation
adverse test evaluation
biological end point identification
biotechnology
simulated use model development
adverse event analysis
Company Information
-
Employees 1
-
Founded 2021
Location
1685 Maine 102, Mount Desert, Maine, United States, 04660
