Provide Independent Third-Party Assessments (FDA/QSR
Logistics
Support NIOSH Submissions for N95 Respirators
Develop and Implement Process Validation Programs
Provide Sterilization Expertise and Services
Write 510(k)s for Medical Devices
Provide On- and Off-Site Training (QSR
Consulting
ISO 13485
etc.)
Training
Medical Device
QSIT
Support FDA Registration and Listing
ISO 9001)
Develop and Implement Quality Systems and System Procedures
CAPA
Risk Management