What We Do
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Company focus: Bio Guidance’s principal has 40 plus years’ experience in medical devices and Infectious disease consulting. Has been an Infection Preventionist in Acute care Hospitals and LTAC’s. Is CIC certified with a PhD in Epidemiology. Member of APIC, SHEA, and ASM. She is CIC board certified through 2028.
History of BioGuidance: As a Founder of a medical device company she developed over 70 IVD products, many are still on the market place. Products were distributed worldwide. Recipient of multiple grants from the DOD for development of infectious disease kits. Expert in Bio-Safety considerations with select agents.
We can train your staff in infection Control processes. We can review and edit documents. Expert Guidance in HAI prevention, Emergency Preparedness, Ebola training, and prevention of C. difficile and prevent C. auris infections.
We can help you navigate nursing home infectious issues.
Bacterica everywhere.... computers, curtains, desktops, phones
INTRODUCTORY CONSULTATION for any Healthcare Challenge
Are you considering doing a construction project in high acuity area of the health care environment?
Does your staff and do your contractors know all the issues associated with Infection Control Risk Analysis known as ICRA?
Do they have appropriate barriers and negative pressure equipment?
Is your EVS staff trained for the challenge of dust and mold control?
Let BioGuidance guide you through the process.
Call or email us with your needs....
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 liaison
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 and curtains, are your computers a source of infection? What disinfectants are you using?
See Power Points and webinars on Resources page. Call with any Questions.