Nilo Medical Consulting Group

What Nilo Medical Consulting Group does

Nilo Medical Consulting Group, LLC (NMCG) is a boutique regulatory and clinical research consulting firm founded in 2016 by Michael Nilo and headquartered in Pittsburgh, Pennsylvania. The firm provides expert regulatory strategy and submission support, full-service and à la carte clinical trial management, quality systems development, and product lifecycle services to medical device, pharmaceutical, biotechnology, and combination product companies ranging from early-stage startups to established global firms across US, EU, and other key markets. NMCG's core technical capability is concentrated regulatory and clinical expertise rather than technology products — the firm prepares 510(k), De Novo, PMA, and IDE submissions, facilitates FDA interactions, secures Breakthrough Device and Safer Technologies Program (STeP) designations, develops QMS frameworks compliant with 21 CFR 820, ISO 13485, and ISO 14971, and runs clinical trials from protocol design through close-out. The firm played a key role in the first device cleared through FDA's STeP and has supported numerous 510(k) and De Novo clearances for clients.

NMCG operates on a professional services revenue model with project-based and retainer engagements, delivered through a sales-led go-to-market motion centered on direct outreach, referrals, industry events, and thought leadership content (including the weekly 'Trying to Keep Up' live call/podcast). The firm employs approximately 10 core staff members (led by President Michael Nilo, a former FDA lead reviewer, and VP Megan Lamberti) supplemented by a network of approximately 30 affiliated consultants including former FDA reviewers. Distribution is purely direct, with no third-party channel partners, resellers, or marketplace presence; pricing is quote-based and not publicly disclosed. The firm is privately held, bootstrapped with no disclosed external funding, structured as a Pennsylvania LLC, and maintains active GTM partnerships with LSI (Life Science Intelligence), RAPS, Greenlight Guru, and the indieMedTech community platform.

Name

Nilo Medical Consulting Group

Legal name

Nilo Medical Consulting Group, LLC

Website

https://nilomedicalconsulting.com

Company type

Private

Founded year

2016

Operating status

Operating

Headcount range

1–10 employees

Short description

Nilo Medical Consulting Group is a Pittsburgh-based boutique regulatory and clinical research consulting firm founded in 2016 that provides 510(k)/De Novo/PMA submission support, FDA interaction management, clinical trial services, and quality systems consulting to medical device, pharmaceutical, and biotech companies from startups to global firms.

Ownership category

akta.pro rank

Product category

Medical Device Regulatory Consulting

NAICS

Other Scientific and Technical Consulting Services (54169), Scientific Research and Development Services (5417)

SIC

Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Regulatory Strategy & Global Submissions (IND/CTA/NDA/BLA/MAA) (HLAGAKAA)

akta.pro secondary industries

Clinical Quality Assurance (GCP QA, TMF/QMS oversight) (HLAGAKAI), CMC & Pharmaceutical Development (Formulation/Process/Analytical Development) (HLAIALAD)

Keywords

• Medical device regulatory consulting
• Clinical research services
• FDA submissions consulting
• Quality management systems
• Regulatory affairs services

Headquarters

HQ city

Pittsburgh

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Marketing or Sales, Technology or R&D

Revenue model

1. Regulatory Consulting Services: Expert guidance through regulatory strategy and submissions including 510(k), De Novo, PMA, IDE, and global submissions; FDA interactions; Breakthrough Device and STeP designation guidance; quality system development and support; product development and design controls; specialized medical writing; reimbursement strategy.
2. Clinical Research Services (Boutique CRO): Full-service CRO support for clinical trials including protocol design and execution, site management, monitoring, safety oversight, data management, clinical study reporting, and close-out. Services can be tailored as full-service or à la carte.

Go-to-market motion1 record

Distribution channels2 records

Marketing channels6 records

Core offering

NMCG is a boutique regulatory consulting and clinical research services firm that helps medical device, pharmaceutical, and biotechnology companies navigate regulatory pathways and clinical trials. Its offerings span four service lines — Regulatory Services (510(k), De Novo, PMA, IDE, and global submissions plus Breakthrough/STeP designations), Clinical Services (full-service or à la carte CRO support for clinical trials), Quality Services (QMS per 21 CFR 820, ISO 13485, ISO 14971), and Product Lifecycle Services (design controls, human factors, V&V planning).

Product overview

Nilo Medical Consulting Group (NMCG) is a boutique regulatory consulting and clinical research services firm founded in 2016. The company offers four integrated service lines: Regulatory Services (covering FDA submissions, global regulatory strategy, and Breakthrough/STeP designation guidance), Clinical Services (full-service CRO support including protocol design, site management, monitoring, and data oversight), Quality Services (QMS development supporting 21 CFR 820 and ISO 13485), and Product Lifecycle Services (design controls, risk management, human factors, and V&V planning). Additionally, the company produces 'Trying to Keep Up (TTKU),' a weekly live call series covering FDA regulatory updates. NMCG also provides specialized consulting through affiliated consultants for human factors engineering, quality systems, EU MDR compliance, reimbursement strategy, and SaMD/digital health guidance.

Differentiator

Problem solved

Functional benefit

Products and services

• Regulatory Services Expert guidance through every stage of regulatory strategy and submissions, including preparation of 510(k), De Novo, PMA, IDE, and global submissions; facilitation of FDA interactions and Q-Submissions; and securing designations such as Breakthrough Device and Safer Technologies Program (STeP). Target customers are medical device, pharmaceutical, and biotechnology companies in the U.S. and EU.
• Clinical Services Full-service boutique CRO support for efficient, compliant clinical trials, covering protocol design, site management, monitoring, data oversight, safety oversight, clinical study reporting, and study close-out. Offered as full-service or à la carte engagements. Target customers are medical device, pharmaceutical, and biotechnology sponsors across multiple therapeutic areas.
• Quality Services Comprehensive quality system development and support, including QMS frameworks meeting 21 CFR 820 and ISO 13485, risk management under ISO 14971, and preparation for audits, inspections, and post-market requirements. Target customers are medical device, pharmaceutical, and biotechnology manufacturers needing QMS implementation or remediation.
• Product Lifecycle Services Strategic support across the product lifecycle, encompassing design controls, risk management, usability and human factors, verification and validation (V&V) planning, and regulatory-aligned development. Target customers are medical device manufacturers seeking end-to-end support from early concept through global market entry.

Quantifiable outcome

• Helped clients secure numerous 510(k) and De Novo clearances
• +3 more outcomes

Named customers1 record

Segments4 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Partnerships

Four partnerships are on record, tiered core and minor.

• LSI (Life Science Intelligence)coreGTM or Marketing Partner · 18 March 2026NMCG President Michael Nilo participated as a panelist at LSI USA 2026 (March 16-20, Dana Point, California) on the panel 'From Scratch to Series A: Do's and Don'ts.' VP Megan Lamberti also participated as a panelist at LSI Europe '25 (September 7-11, London) on the panel 'Clinical Traction: Generating Investor-Ready Data Through Strategic Site Partnerships.' LSI is the premier event for medtech innovation and investment.
• Greenlight GurucoreGTM or Marketing Partner · 19 November 2025NMCG President Michael Nilo joined Greenlight Guru for an Ask Me Anything (AMA) session at their Virtual Summit 'The Future of MedTech' on November 19, 2025, discussing major regulatory changes and their implications for growing medtech companies. Greenlight Guru provides quality management software and hosts the Global Medical Device Podcast where Michael appeared.
• RAPS (Regulatory Affairs Professionals Society)minorGTM or Marketing Partner · 8 October 2025NMCG hosted a mixer and strategy session timed to coincide with RAPS Convergence 2025 in Pittsburgh on October 8, 2025, at Bakersfield Tacos. The event was designed for regulatory affairs professionals, medical device companies, and hiring managers to network and discuss medtech strategy.
• indieMedTechcoreStrategic or Co-development PartnerCo-founded by NMCG affiliated consultant Holly Cotter (Founder and Principal Consultant of White Lamb Consulting), indieMedTech is the newest social and professional network dedicated to MedTech professionals. The platform enables professionals to collaborate, build partnerships, and access resources that elevate industry expertise. NMCG featured the platform at their RAPS Convergence mixer event.

Scale indicators4 records

Recent moves5 records

Expansion highlights5 records

Direct peers

• Medpace: Medpace is a mid-size full-service CRO with a strong medical device and regulatory practice, offering protocol design, monitoring, and submission support - overlapping directly with NMCG's clinical services and regulatory submission work, though at meaningfully larger scale.
• Advarra: Advarra provides IRB review, regulatory consulting, and clinical research technology to medical device and pharma sponsors - an analogous services-led firm with overlapping regulatory and clinical-trial customer base.
• Clinipace Worldwide: Clinipace is a mid-size, adaptive CRO providing clinical trial management and regulatory services to medical device and biopharma sponsors, comparable in operating philosophy to NMCG's boutique full-service-or-à la carte delivery model.
• NAMSA: NAMSA is the largest CRO/regulatory consultancy dedicated to medical devices, providing regulatory strategy, clinical trial support, and quality services comparable to NMCG's full-service med-device regulatory and clinical offerings.
• Worldwide Clinical Trials: Worldwide Clinical Trials is a mid-size CRO with regulatory consulting and clinical operations across medical device, rare disease, and CNS - directly comparable to NMCG in offering integrated regulatory strategy and clinical trial execution.
• Premier Research: Premier Research is a mid-size CRO with significant medtech and biotech regulatory/clinical capabilities, including 510(k)/IDE support and clinical trial management - a comparable operating model to NMCG's integrated consulting-plus-CRO offering.
• Veranex (formerly MCRA): Veranex (formed by MCRA's combination with other medtech CROs) is a medical device-focused regulatory, clinical, and quality consulting firm serving device manufacturers across all classes - a direct boutique-to-mid-size competitor to NMCG with substantially greater scale.

Broad incumbents

• Syneos Health: Syneos Health is a large full-service CRO offering clinical development, regulatory, and commercial services across therapeutic areas, including medical devices - a broad incumbent competitor to NMCG at the upper end of the market.
• IQVIA: IQVIA is the world's largest CRO with extensive medical device, pharma, and biotech regulatory and clinical capabilities - a broad incumbent that competes with NMCG on larger enterprise programs while NMCG serves overflow and boutique-tier work.

Emerging players

• Greenlight Guru (a Rimsys company): Greenlight Guru (now part of Rimsys) provides eQMS and regulatory workflow software plus community-based content for medtechs - closely adjacent to NMCG via the QMS/quality systems services line and the Greenlight Guru + NMCG co-marketing relationship.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/nilo-medical-consulting-group-llc
• Facebookfacebook.com/nilomcg

Revenue estimate

Valuation estimate

Number of profiles

Profiles10 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Nilo Medical Consulting Group