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