Regulatory consulting services at competitive rates in the medical device and combination product industries

Nilo Medical Consulting

Assisting medical companies through the regulatory process

Nilo Medical Consulting Group is a limited liability company that provides medical industry consulting services based out of the Pittsburgh, PA and Portland, OR areas.

The principal, Michael Nilo, has 10 years of experience in the medical device industry, including 5+ years as a lead reviewer at the Food & Drug Administration. He has direct experience with FDA device review processes and intricacies. He has hands-on familiarity with most functions and departments of a successful medical device company, and has provided consulting advice for verification and validation testing, quality systems, and regulatory submissions for all different classes of medical devices. He has also authored and submitted applications to FDA for Class II and III medical devices.

Nilo Medical Consulting Group helps clients navigate the US FDA regulatory environment with special expertise in medical devices and combination products. It is available to teach courses and provide templates to regulatory affairs professionals, students, or other interested parties.

Our customers are small to large businesses that provide or wish to provide design, manufacturing, or sales of medical devices in either the US or EU, and that either have limited internal expertise for a given market, regulatory, or technical issue, or who wish to provide surge capacity or enlist the help of a domain expert.

Medical devices are a growth industry, and the regulatory environment is ever-changing.  Nilo Medical Consulting Group provides expertise to meet that demand.


Life’s most persistent and urgent question is, ‘What are you doing for others?’
— Martin Luther King, Jr.