The 9 top medical device consulting firms you should consider for 2024


    Which are the top medical device consulting firms your business should look at for your 2024 plans?

    The right consultant expertise can speed up your company's time to market, help you pass regulations, and help you foster a quality-driven approach that sets your business apart.

    We've built our list of the best expert teams available - and given them our Top Medical Device Consultant award to show off their position as among the industry's best.



    Table of Contents

    1. The 9 top medical device consulting firms in 2024

      1. QES Medical
      2. Rook Quality Systems
      3. MWA Consulting/AVS Life Sciences
      4. Cannon Quality Systems
      5. Effectum Medical
      6. Medpoint
      7. Red Medtech
      8. NorMed Consulting
      9. Platypus MedTech Consulting
    2. The value of medical device consulting firms



    The 9 top medical device consulting firms in 2024


    The top medical device consulting firms for 2024 include a broad mixture of consultancies with varying specializations. The top firm for your company is likely to vary based on numerous factors, including your project goals, company size, location and budget.

    The wisest way to choose quality management consulting firms to interview is to understand your needs in advance. Evaluate whether you need project-based support, or if you would be better served with a long-term outsourcing agreement.

    Being realistic about your needs and expectations can help you narrow your options significantly and find the best firm.


    1. QES Medical


    Boston-based QES Medical is a consulting firm, founded in 2009, providing a variety of quality, regulatory and software development consulting services to the medical device industry, as well as to the pharmaceutical industry.

    Founder and President Oscar Garcia has a wealth of industry experience (20+ years), including leadership roles in various Boston Area-based medical device companies.

    The QES team offer targeted expert services around:

    • QMS building and support
    • QMS audits
    • FDA compliance remediation
    • Health Hazard Evaluations (HHE)
    • Regulatory compliance with key standards like ISO 13485 and FDA 21 CFR 820
    • Design and development
    • Risk management
    • Regulatory submission and support
    • Software as medical device (SaMD)


     And more. 


    2. Rook Quality Systems


    RookQS celebrates its 12th birthday in 2024.

    The Rook team of 36 experts includes 13 certified quality auditors with a range of international medical device experience.

    'Look to Rook' if you need consultancy support for key medical device quality and compliance hurdles, like:

    • The MDSAP
    • EU MDR CE marking
    • ISO 13485

    Whether you're a hardware, SaMD or IVD company, from Class I to III, the Rook team can help.


    RELATED READING: The pros and cons of medical device consulting




    3. MWA Consulting/AVS Life Sciences


    MWA are established players in the life science consulting space, with over 300 associates scattered across the US, Canada, India, South America and Europe.

    MWA's central mission is to help clients embed GxP.

    For medical device companies, this means expert support for:

    • QMS-building
    • Preventative maintenance
    • 510(k) submission
    • Risk management, including hazard analysis, FMECA and FTA
    • Internal audits


    And more.

    Plus, the company was recently acquired by AVS Life Sciences, creating a boosted operation with even greater reach.


    4. Cannon Quality Group


    Cannon Quality Group  was founded in 2010 as a full-service outsourced quality management company for medtech, IVDR and SaMD medical device companies, as well as pharmaceutical clients.

    Cannon's specialty is arming clients with robust quality management systems for long-term success.

    Founder Nicolle Cannon was inspired to begin the business by the inefficient, fear-based quality systems she encountered in previous roles.

    Along with helping clients with all the key ingredients of good quality management - like slicing costs and boosting efficiency - Cannon Quality Group also pioneered the time-saving Audit Efficiency Program, where suppliers can be audited by the Cannon team on behalf of multiple clients in a single session.


    RELATED READING: 4 regulations that apply to medical device CRO selection



    5. Effectum Medical


    Switzerland-based Effectum Medical offers two services to its diverse range of medical device customers:

    1) Outsourced quality management via a 'plug-and-play' eQMS document set of 30 SOPs and over 150 templates, run within Qualio

    2) Acting as a legal manufacturer and Authorized Representative to accelerate access to the European markets

    The Effectum team of medtech experts offers a hands-on, collaborative partnership to help customers innovate and embed lasting compliance with the requirements of ISO 13485, the FDA, and the EU's MDR and IVDR.



    6. Medpoint


    US-based Medpoint is a fantastic all-round consultancy offering, serving clients with a huge range of medical device consulting services.

    From QA support around core regulatory milestones like FDA 21 CFR 820 or MDSAP compliance, to clinical support, technical consulting, and even global supplier auditing services, Medpoint's team of 350 global consultants are standing by to assist your organization.



    7. Red Medtech


    Wales-based Red Medtech specialize in slipping seamlessly into client projects to guide them to success.

    Red Medtech's expertise is process, joining clients at any stage of their lifecycle to help them build, understand, embed and apply detailed procedures and processes for:

    • Product design
    • Technical spec writing
    • Engineering
    • ISO 13485 QMS-building
    • Building and leading project teams
    • Creating/submitting regulatory documents

    Among others.


    8. NorMed Consulting


    The NorMed team, based in Copenhagen, is a seasoned bunch available for remote or hybrid hire in a range of flexible contract types to suit you.

    From SaMD and AI devices to combination products and classic hardware, NorMed specialize in helping clients crack compliance in the EU, UK and USA. 

    Their focus? To guide clients down a rapid, right-first-time route to market success with minimal friction and maximum quality and patient focus.


    9. Platypus MedTech Consulting


    This team of Australian experts is led by Dr. Lee Walsh, who also made our list of the top 10 quality consultants you should work with this year.

    Platypus provides a host of expertise to support regulatory submissions, particularly for TGA and ISO requirements, and is particularly strong in digital health, cybersecurity and SaMD considerations.

    We've seen Platypus' expertise first-hand: they steered one of our customers to a new chapter of quality and helped them bring their innovative wellness product to the Australian market.

    Need targeted medical device support Down Under? Look no further.



    The value of medical device consulting firms


    There’s more than one reason to hire a consulting firm. Medical device companies can benefit from consultants in many different ways. The right consultant can help create a strategy, implement quality management system (QMS) software, or navigate high-stake situations such as device filings.

    Some consultancies can also offer quality management services that incorporate ongoing support and full outsourcing. Entering into a recurring agreement to outsource quality management or compliance to experts can allow medical device firms to achieve a quality-driven culture and focus on what they do best—innovation.