Basic info
Industry
medical equipment manufacturing
Sectors
regulatory strategy
Medical Device
risk management
ISO 13485
sterilization validation
biocompatibility
microbiology
cleanroom qualification
document control
design transfer
predicate selection
bioburden testing
risk planning
FDA 483
Health Care
medical device consulting
design controls
audits
510(k) premarket submissions
quality management systems
process validations
endotoxin
Date founded
2000