Let BioGuidance help you.
What we do:
1. IVD Consulting:
a. Designing studies for 510k submission. Site coordination
b. Data analysis
c. Writing 510k and other regulatory submissions.
d. FDA liason
e. Design control and GMP and FDA inspection readiness
2. A Trained Epidemiologist: Meet CMS and Joint Commission Standards
a. Inspection readiness… Can help your hospital be compliant with CMS regulations and Joint Commission Standards.
b. Staff training and workshops. A professor at several colleges and universities, she can help your staff stay current on regulations
c. Are your infections rates where they should be?
What’s growing on your counters, are your computers a source of infection? What disinfectants are you using?
3. Surgi-Center Accreditation compliance: Are you ready to meet the new standards…..
a. new CMS rules, inspection readiness documentation, corrective action plans, training and observation.