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