The top 7 medical device consulting firms you should consider for 2023

    Which are the top medical device consulting firms your business should look at as we approach 2023? 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.

    Table of Contents

    1. The top 7 medical device consulting firms in 2023

      1. QES Medical
      2. Rook Quality Systems
      3. MWA Consulting
      4. Cannon Quality Systems
      5. Sigma Systems
      6. Apotech Consulting
      7. Windshire Consulting

    2. The value of medical device consulting firms

    The top 7 medical device consulting firms in 2023

    The top medical device consulting firms for 2023 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 serves some pharmaceutical clients too, but its primary expertise lies in the medical device space.

    Founder and President Oscar Garcia has a wealth of industry experience (18+ years), including a Quality Director role for Cambridge-based Common Sensing.

    The QES team offer targeted expert services around:

    • QMS building and support
    • Regulatory compliance with key standards like ISO 13485 and FDA 21 CFR 820
    • Design and development activity
    • Risk management
    • Audit readiness

    And more.

    2. Rook Quality Systems

    RookQS celebrated its 10 birthday in 2022.

    The Rook team includes 11 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

    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.

    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. Sigma Systems

    Serbia-based Sigma Systems specialize in quality and compliance consultancy for medical device companies.

    The 12-strong team brings a range of experience to assist clients with complex quality tasks, such as:

    • Technical File creation
    • CE marking
    • QMS gap analysis

    The Sigma team also offers targeted workshops for key topics like ISO 14971, IEC 62304, the EU MDR/IVDR, and more.

    6. Apotech Consulting

    Apotech boasts a large team of engineering, quality and regulatory experts, including IRCA-trained auditors.

    As a so-called contract service organization (CSO), Apotech positions itself as an outsourced partner supporting the end-to-end device development process.

    With twin offices in London and Paris, Apotech specializes in helping non-European medical device clients crack the requirements of the MDR and IVDR and get to the EU market.

    From quality management consultancy in areas like CAPAs and root cause investigation, to validation and engineering support for SaMD clients, Apotech is a safe bet for any medical device company needing an expert touch.

    7. Windshire Consulting

    Windshire's primary focus is pharmaceutical and biopharmaceutical consultancy, but they also offer a range of services for medical device clients.

    Windshire's expertise is process, helping clients to understand, embed and apply detailed procedures and processes for:

    • Product design
    • Operational excellence (lean)
    • Data and automation integration
    • Manufacturing and technical operations
    • Outsourcing and supply chain
    • CMO selection/oversight
    • Packaging and shipping
    • Product and technology assessments

    Among others.

    Windshire also offers talent sourcing and its own product portfolio, including a Part-11-compliant eQMS hosting solution and its Trainingshire training platform.

    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.

    At Qualio, we've developed the world's leading enterprise quality management system (eQMS) for medical device start-ups and scale-ups.

    Just contact us, and we'll find the best fit for you.