Michael Nilo

Michael Nilo, MS is President & Principal Consultant at Nilo Medical Consulting Group. A former FDA lead reviewer with more than 15 years in the medical device industry, he has deep expertise in regulatory strategy, quality systems, and clinical trial development. Michael has authored and submitted numerous 510(k), De Novo, IDE, and PMA applications and is known for guiding clients through complex FDA and global requirements with precision and clarity.

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Ultimate Guide to Comparing Quality Management System Solutions

Michael Nilo

Recent Posts

How a Government Shutdown Affects FDA Medical Device Regulation

Software as a Medical Device: Securing Your Digital Future

CSV vs. CSA: Breaking Down the FDA's Guidance on Computer Software Assurance

Focus on the Work That Matters Most.

Featured Capabilities:

Featured Capabilities:

Ultimate Guide to Comparing Quality Management System Solutions

Michael Nilo

Recent Posts

How a Government Shutdown Affects FDA Medical Device Regulation

Software as a Medical Device: Securing Your Digital Future

CSV vs. CSA: Breaking Down the FDA's Guidance on Computer Software Assurance

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Focus on the Work That Matters Most.