Profile

Michael Nilo

RegEx Rising Star
RegEx Pro

Bio

I am currently working as an independent contractor available for consulting assistance with FDA processes. I am an accomplished biomedical engineer with extensive knowledge of FDA regulations. I have worked with a regulatory group attempting to launch innovative vascular interventional products in the US Market. Previously, I worked in the Office of Device Evaluation at the FDA and examined pre-market submissions for cardiac medical devices, specifically devices that are inserted into the coronary arteries and the devices used in the interventional procedure. Drug eluting stents, atherectomy systems, percutaneous transluminal coronary angioplasty balloons, guide catheters, and embolectomy catheters are just a few of the devices that I am responsible for reviewing. Previously, I reviewed dental devices such as implants, abutments, bone-grafting materials, bone plates, and trans-mandibular joint implants.

Specialties: Cardiovascular devices, FDA regulations, project management, biomedical engineering, thermodynamics, vascular intervention

www.nilomedicalconsulting.com

Education

University of Alabama at Birmingham
Birmingham, Alabama, United States
M.S.
Biomedical Engineering
2007 To 2009
Dissertation: Mechano-dependent regulation of TGF-β1 in Aortic Valve Interstitial Cells
Advisor: W. David Merryman, PhD

University of Pittsburgh
Pittsburgh, Pennsylvania, United States
B.S.
Bioengineering, Chemistry
2003 To 2007

Current Organization Type

Self-employed Consultant

Job History

Network Regulatory Partners
Senior Regulatory Affairs Consultant
December 2016 - present

Nilo Medical Consulting Group, LLC
President
November 2016 - present

The FDA Group, LLC
Senior Regulatory Affairs Consultant, (Contractor)
November 2016 - present

Vision28
Senior Regulatory Consultant
November 2016 - present

FDA
Lead Reviewer / Biomedical Engineer
White Oak, MD, United States
November 2009 - May 2015

Product Interests

Biomaterials, Biotechnology, Combination Products, IVDs, Medical Devices