Avio Medtech Consulting

What Avio Medtech Consulting does

Avio Medtech Consulting is a Minnesota-based professional services firm, founded in 2021 by medtech entrepreneur and engineer Morgan Evans, that provides integrated regulatory affairs, quality assurance, and R&D program management consulting to early-stage medical device startups. The firm targets early-stage medtech companies across Class I, II, and III devices, with a particular emphasis on first-time founders, and supports clients through FDA pathway navigation (510(k), De Novo, PMA, Breakthrough Device Designation), QMS implementation (ISO 13485, MDSAP), design controls, vendor and manufacturing transfer oversight, and commercialization planning via the in-house Navigator Network of C-suite advisors. Service engagements are delivered through embedded consultant teams that operate as integrated members of client organizations rather than through channel partners or resellers.

The business model is professional services, with project-based and retainer pricing tailored to client stage and scope. Avio supplements direct engagement revenue with ecosystem marketing — content (blog insights and the Lift Off newsletter), webinars, the MedTech Roadshow across multiple US cities, the annual Avio Medtech MVP Pitch Contest awarding non-dilutive funding, and CEO roundtables — to generate demand among medtech founders and venture investors. The company states it has supported 150+ startups since founding, with 100+ client partners referenced at the five-year mark, and cites an active book of named clients spanning ultrasound contrast, fistula/ostomy management, diagnostics, surgical devices, and sexual health.

Avio is privately held by founder Morgan Evans with no disclosed institutional funding. It is governed by a Board including Board Chair Amy Langer, Executive Chairman Mark Summers, and Independent Director Carmen Volkart (joined April 2025), with a Managing Director for EU operations and a broader team of roughly 20 professionals plus a Navigator Network of senior advisors. Strategic and ecosystem partnerships with Accelermed (commercialization), Destination Medical Center, Fredrikson & Byron, F&N Med, Mobius Medical, Medtech MVP / Cambridge Innovation Institute, Forj Medical, BayCath Medical, and CLA reinforce the integrated go-to-market and broaden the firm's footprint within the medtech startup ecosystem.

Name

Avio Medtech Consulting

Legal name

Avio Medtech Consulting, LLC

Website

https://aviomedtech.com

Company type

Private

Founded year

2021

Operating status

Operating

Headcount range

11–50 employees

Short description

Avio Medtech Consulting is a St. Paul, Minnesota-based consulting firm founded in 2021 that provides integrated regulatory affairs, quality assurance, R&D program management, and C-suite advisory services to early-stage medical device startups.

Ownership category

akta.pro rank

Product category

Medical Device Regulatory Consulting

NAICS

Management Consulting Services (54161), Other Management Consulting Services (541618)

SIC

Services-Management Consulting Services (8742)

akta.pro primary industry

Risk, Compliance & Internal Controls Consulting (BPAHACAJ)

akta.pro secondary industry

Corporate Strategy Advisory (BPAHADAA)

Keywords

• Medical device consulting
• Regulatory affairs services
• FDA submission support
• Quality assurance consulting
• R&D program management

Headquarters

HQ city

Minnesota City

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 Affairs Consulting: End-to-end regulatory strategy and submission services including FDA pathway navigation, 510(k), De Novo, PMA submissions, Breakthrough Device Designation, and ongoing regulatory relationship management with FDA.
2. Quality Assurance Consulting: Quality management system implementation, ISO 13485 and MDSAP readiness, design controls, SOP development, risk management, and audit support services.
3. R&D Program Management: Product development planning, cross-functional milestone management, vendor oversight, manufacturing transfer support, and technical documentation services.
4. C-Suite Navigator Network: Access to experienced medtech C-suite leaders and founders for strategic advisory, coaching, and operational support through the Navigator Network.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels5 records

Core offering

Avio Medtech Consulting is a professional services firm that partners with early-stage medical device startups to deliver integrated regulatory affairs, quality assurance, R&D program management, and C-suite advisory services. The firm operates as an embedded co-pilot, providing direct consultants who work inside client teams on FDA pathway strategy, submissions (510(k), De Novo, PMA, IDE, Breakthrough Device Designation), quality system implementation (ISO 13485, MDSAP), product development execution, and senior-level strategic guidance via the Navigator Network.

Product overview

Avio Medtech Consulting is a consulting services firm (not a software product company) that offers an integrated suite of four core services for medtech startups: Regulatory Affairs Services (FDA strategy and submissions), Quality Assurance Services (QMS implementation and ISO 13485/MDSAP compliance), R&D Program Management (product development and design controls), and the C-Suite Network/Navigator Network (access to experienced medtech executives as strategic advisors). These services are designed to work together as an integrated consulting model that supports medtech companies across the full product lifecycle, from concept through commercialization.

Differentiator

Problem solved

Functional benefit

Products and services

• Regulatory Affairs Services End-to-end regulatory strategy and FDA submission services for medical device startups, covering pathway strategy, Pre-Submission planning, Breakthrough Device Designation pursuit, global market expansion, and full submissions for 510(k), De Novo, PMA, and IDE pathways.
• Quality Assurance Services Quality management system implementation and compliance services covering QMSR gap assessments, ISO 13485 and MDSAP readiness, SOP development, design controls, risk management, supplier quality, CAPA management, and FDA audit support for medical device startups.
• R&D Program Management (R&D PM) End-to-end product development planning and program leadership for medical device startups, including cross-functional milestone management, design control management, vendor oversight, manufacturing transfer, DHF/DDF development, traceability matrices, technical writing, V&V planning, usability strategy, and cybersecurity management.
• C-Suite Network / Navigator Network Curated access to experienced medtech C-suite leaders and founders who serve as strategic co-pilots, providing senior-level guidance on fundraising, commercialization, product strategy, business operations, and M&A for early-stage medical device companies.

Quantifiable outcome

• Supported 150+ startups since founding in 2021
• +3 more outcomes

Named customers6 records

Segments3 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Partnerships

Nine partnerships are on record, tiered core and minor.

• AccelermedcoreStrategic or Co-development Partner · 8 February 2025Avio and Accelermed partnered to address early commercial planning for medtech startups, combining Accelermed's commercialization expertise with Avio's regulatory, quality, and R&D capabilities to reduce startup failure rates.
• Destination Medical Center (DMC)minorGTM or Marketing PartnerPartnership for the annual Medtech MVP Pitch Contest and broader ecosystem development in Minnesota's medical technology corridor.
• Fredrikson & Byron, P.A.minorStrategic or Co-development PartnerLegal partner for pitch contests providing healthcare and life sciences expertise for startup ecosystem events.
• F&N MedminorGTM or Marketing PartnerSpecialized medtech branding practice partnering on pitch contests and ecosystem events.
• Mobius MedicalminorStrategic or Co-development PartnerGlobal contract research organization specializing in clinical trial management partnering on pitch contests and ecosystem events.
• Medtech MVP / Cambridge Innovation InstituteminorGTM or Marketing PartnerPartnership for annual pitch contests awarding non-dilutive funding to medtech startups at their Venture & Partnering Conference.
• Forj MedicalminorStrategic or Co-development PartnerHost partner for Avio Medtech & Forj Medical CEO Roundtables bringing together startup leaders for dialogue on medtech growth environment.
• BayCath MedicalminorGTM or Marketing PartnerPartner in 2026 MedTech Roadshow events in Houston and Mountain View.
• CLA (CliftonLarsonAllen)minorGTM or Marketing PartnerAccounting and advisory firm partner for 2026 MedTech Roadshow events.

Scale indicators3 records

Recent moves5 records

Expansion highlights5 records

Direct peers

• RQM+: RQM+ is a medtech-focused regulatory and quality consulting firm that helps medical device companies with FDA submissions, ISO 13485, MDSAP, and QMS implementation. It is the closest direct competitor to Avio, serving overlapping startup and growth-stage medtech clients with a similar integrated regulatory/quality value proposition.
• BioTeknica: BioTeknica is a medical device regulatory, quality, and clinical consulting firm serving companies from concept through commercialization. It directly competes with Avio in the same startup and emerging medtech segment, particularly on QMS implementation, regulatory submissions, and audit support.
• MethodSense: MethodSense is a medical device regulatory and quality consulting firm offering services spanning FDA strategy, ISO 13485, MDSAP, and product development support. It is a direct competitor in the same boutique medtech regulatory advisory category as Avio.
• StarFish Medical: StarFish Medical is a medical device design, development, and regulatory services firm serving startups through commercialization. It overlaps with Avio on the R&D program management and regulatory strategy side, particularly for North American medtech startups.
• Meddux Development Corporation: Meddux is a medical device development and manufacturing services firm supporting product development, regulatory, and quality work for medtech innovators. It is comparable to Avio in serving early-stage medtech clients with bundled development and regulatory expertise.
• AcKnowledge Regulatory Strategies: AcKnowledge Regulatory Strategies is a medical device regulatory affairs consultancy supporting FDA submissions, quality systems, and clinical strategy for medtech companies. It is a direct boutique competitor to Avio's regulatory affairs service line.

Broad incumbents

• NAMSA: NAMSA is one of the largest medical device-focused CROs and consulting organizations, offering regulatory, quality, clinical, and laboratory services. It is a broader incumbent that competes with Avio for regulatory and quality work while also offering complementary clinical and testing capabilities Avio does not provide.
• IQVIA (Medtech Practice): IQVIA is a global CRO and life sciences services leader with a substantial medical device regulatory and quality practice. It competes with Avio primarily at the larger end of the market but increasingly extends modular offerings down into venture-backed medtech startups.

Emerging players

• Greenlight Guru: Greenlight Guru is a medtech QMS software and consulting platform targeting the same startup segment Avio serves. It represents an emerging, technology-enabled alternative that competes on quality system implementation and may, over time, displace portions of Avio's QMS consulting work.
• ProMedoss: ProMedoss is a medtech consulting and staffing firm offering regulatory, quality, and clinical services to medical device companies. It is an emerging player that overlaps with Avio's consulting service lines, particularly in serving resource-constrained medtech ventures.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/avio-medtech

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 Avio Medtech Consulting