MicroIVD Consulting

Let’s Succeed Together

About Me

I’ve been a professional in the field of Diagnostics Microbiology since the 90s, with several (>20) FDA 510(k) "clearance" accomplishments since the early 2000s. I believe in maintaining a positive mindset, creating partnerships with a purpose, and always striving for significant outcomes. When you work with me on the introduction of your microbiology device aiming for the FDA clearance and introduction to the market, you should expect a collaboration with transparency, consistency and proven track of results. Want to learn more? Contact me today for an initial consultation.

Services

Comprehensive product assessment of performance
Market research on the product potential
Business intelligence analysis and interaction with Key Opinion Leaders (KOLs)
Q-sub (pre-submission) preparation
Interaction with the FDA
Study design, planning of clinical studies
Coordination of clinical trial
Data analysis
Assembly of 510(k) submission
Interactive review engagement with the FDA all the way until the product's 510(k) clearance
Medical writing for publication in peer reviewed journals

Strategizing

The Path to Success

Do you have a product, project or idea that you’d love to bring to life? Since founding my business, I’ve provided my clients with a wide range of consulting services such as this one. To find out more, get in touch.

Implementation Planning

Expert Guidance

My services are customized to meet the specific needs of each client. I work collaboratively throughout the entire process and guarantee measurable results. Contact me to find out how I can help today.

Free Consultation

Without doubt, 510(k) can be a long and laborious process,

if you believe in the potentials of your microbiology in-vitro diagnostics device, let's chat, assess and start the process. Please send me an email at microivdconsulting@yahoo.com