"Experienced advice, good communication." -Satisfied Customer
"Michael & his team were tenacious, experienced and a great advocate for our company with the FDA. They helped walk us through a very trying process that was part of our inexperience..." -Mark Goettling, CXO at BodiMetrics
"Great to work with! Don't hesitate to work with this team!" -Satisfied Client
"Support by knowledgeable talents with fairness and rapidness. Trust and connections with authorities." -Satisfied Client
"Michael is extremely talented and made all of our regulatory filings successful, not to mention very competitively priced. I like how diligent Michael is with his responses." -Safeguard Surgical
"Nilo Medical Consulting played a critical role in accelerating our time to market with our new to the world medical device." -CEO at LeanMed
"Responsive and knowledgeable" -Satisfied Client
"Good personal relationship. Takes care of each individual customer. Fair pricing. Excellent service." -Christian Weherenfennig, Principal Consultant at Xylem
"Nilo Medical Consulting Group provides unparalleled expertise and guidance in the healthcare industry. Their team's deep understanding of medical regulations and emerging trends ensures we receive top-tier consultation tailored to our needs at LiViliti Health Products. I highly recommend NMCG for their professionalism, knowledge, and dedication to client success." -CEO at LiViliti
"I appreciate the responsiveness and straight forward unfiltered feedback. Thanks." -Don Webber, President and CEO at Bridge to Life Ltd.
"Michael has a solid background of the workings within the FDA and was quickly able to get a read from the branch on the regulatory pathway for our device." -Don Webber, President and CEO at Bridge to Life Ltd.
"Very easy and pleasant to work with. Very knowledgeable!" -Sensoria
"I chose NMCG for the exceptional depth of experience and expertise on the team. I can count on them to either know the answers I'm looking for, or where to find them in short order. I also find their pricing to be very reasonable for the value they add." -Endolumik
"NMCG has been exceptional in supporting our company through two successful 510(k) applications. Even more importantly, they helped us to become the first medical device ever to be cleared through the FDA's Safer Technology Program." -Endolumik
"Experienced advice, good communication." -Satisfied Customer "Michael & his team were tenacious, experienced and a great advocate for our company with the FDA. They helped walk us through a very trying process that was part of our inexperience..." -Mark Goettling, CXO at BodiMetrics "Great to work with! Don't hesitate to work with this team!" -Satisfied Client "Support by knowledgeable talents with fairness and rapidness. Trust and connections with authorities." -Satisfied Client "Michael is extremely talented and made all of our regulatory filings successful, not to mention very competitively priced. I like how diligent Michael is with his responses." -Safeguard Surgical "Nilo Medical Consulting played a critical role in accelerating our time to market with our new to the world medical device." -CEO at LeanMed "Responsive and knowledgeable" -Satisfied Client "Good personal relationship. Takes care of each individual customer. Fair pricing. Excellent service." -Christian Weherenfennig, Principal Consultant at Xylem "Nilo Medical Consulting Group provides unparalleled expertise and guidance in the healthcare industry. Their team's deep understanding of medical regulations and emerging trends ensures we receive top-tier consultation tailored to our needs at LiViliti Health Products. I highly recommend NMCG for their professionalism, knowledge, and dedication to client success." -CEO at LiViliti "I appreciate the responsiveness and straight forward unfiltered feedback. Thanks." -Don Webber, President and CEO at Bridge to Life Ltd. "Michael has a solid background of the workings within the FDA and was quickly able to get a read from the branch on the regulatory pathway for our device." -Don Webber, President and CEO at Bridge to Life Ltd. "Very easy and pleasant to work with. Very knowledgeable!" -Sensoria "I chose NMCG for the exceptional depth of experience and expertise on the team. I can count on them to either know the answers I'm looking for, or where to find them in short order. I also find their pricing to be very reasonable for the value they add." -Endolumik "NMCG has been exceptional in supporting our company through two successful 510(k) applications. Even more importantly, they helped us to become the first medical device ever to be cleared through the FDA's Safer Technology Program." -Endolumik
Nilo Medical Consulting Group is a limited liability company that provides medical industry consulting services based out of Pittsburgh, PA.
The Principal Consultant and Founder, Michael Nilo, has worked in the medical device industry since 2009, including 6 years as a lead reviewer with the US Food & Drug Administration. He has direct experience with FDA device review processes and intricacies. He also 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. Michael has authored and submitted applications to FDA for Class II and III medical devices.
Nilo Medical Consulting Group’s Vice President of Clinical and Regulatory Affairs, Megan Lamberti, has worked in the clinical research and medical device industries since 2012. Megan has gained cross-functional skills and diverse viewpoints in the conduct of clinical research through her experience in industry, clinical research consulting and CRO (clinical research organization) services, and academia. She has worked as a clinical research associate (CRA), monitor, and project director on the CRO side of research. In industry, she has managed clinical affairs on behalf of her clients, and has worked as a clinical research coordinator (CRC) in academia. Megan has successfully designed and led numerous clinical trials across a multitude of medical specialties, which dovetails into her strategic and hands-on regulatory submission support and robust medical and technical writing services.
NMCG helps clients navigate the US FDA and global regulatory/clinical environments with special expertise in medical devices, diagnostics, and combination products, including comprehensive regulatory submission preparation and CRO services.
Our clients are small to large medical device and biotechnology companies in the design, manufacturing, and/or sales phase of medical device development based in the US, EU, and other geographies. Clients may request regulatory or clinical research program management, submission authorship and/or review, strategic advice on a specific regulatory, clinical, or technical challenge, or surge capacity support. We are also available to teach courses and provide templates to regulatory, quality and clinical affairs professionals, students, or other interested parties.
The regulatory and clinical environments of the medical device industry are constantly evolving. Nilo Medical Consulting Group provides strategic knowledge and hands-on expertise to reduce the complexity of these domains, helping clients successfully navigate the path to market.
“Life’s most persistent and urgent question is, ‘What are you doing for others?’”