Top Medical Device Consulting Companies - 2022
Preclintox Services, LLC: Simplifying Biological Evaluation of Medical Devices

Top 10 Medical Device Consulting Companies – 2022

Medical device consulting companies are navigating device manufacturers with an array of turnkey services, system implementation, training, licensing, regulatory approvals, and certifications to help them respond to the unprecedented challenges presented by the pandemic. Consultants are blending their medtech expertise with artificial intelligence (AI), machine learning (ML), additive manufacturing, and 3D printing solutions to manage data and speed-up the time to market.

In terms of technologies, additive manufacturing is making substantial in roads into medical device consulting. By aligning well with the needs of a medical device, additive manufacturing is enhancing product customization, and ensuring its cost-effective production and delivery. These developments are paving the way for the medical devices market to reach $466.5 billion by 2027.

To put the spotlight on such key developments, MedTech Outlook illustrates how medical device consulting companies are leveraging the latest technologies to help medical device manufacturers effectively bring their devices to market. This edition also features thought leadership articles from Joshua Lenchus, DO, Regional and Chief Medical Officer at Broward Health Medical Center, Michael Geraci, Medical Director Comprehensive Spine Program at Catholic Health, and Heitham T. Hassoun, MD, Vice President & Medical Director, Cedars- Sinai Health System, who shed light on the role of EMR in documenting social determinants of health (SDoH), how changing the way patients are treated and referred to other spine care clinicians, and diverse regulatory documentation requirements pertinent today.

In this edition of MedTech Outlook magazine, we also bring to you the story of some of the top medical device consulting companies. In the list, Preclintox Services stands out for its ability to provide consulting services on medical device toxicology, supporting product development, and help manufacturers to conduct safety evaluations in line with the general principles of ISO 10993. We also bring to you the story of Athletic Integrative Medicine, providing medical consulting and a supply chain network with a specific focus on regenerative biologics and medical devices. Equally commendable are the stories of Smith Associates, offering specialized regulatory services for the medical device manufacturers of in vitro diagnostics and biologics.

Through the following pages, we aim to shine a light on the innovative trends and latest developments in the medical device consulting segment. We would like to know your thoughts.  

    Top Medical Device Consulting Companies

    Preclintox Services, LLC
    Preclintox Services is a consultant group that provides consulting services on medical device toxicology, supports product development, and empowers manufacturers to conduct safety evaluations in line with the general principles of ISO 10993.
    Smith Associates
    Since 1994, under the direction of E J Smith, President, Smith Associates has specialized in regulatory services for the medical manufacturers of medical devices, in vitro diagnostics, biologics and blood. This includes the most common route to clearance in the United States, the 510k submission (PMN), and also Pre-Submissions, Pre-IDE, PMA, and Human Factors studies required for validation of the device by the intended use for inclusion in 510ks.
    Athletic Integrative Medicine
    Athletic Integrative Medicine (AIM) is a medical consulting and supply chain network with a specific focus on regenerative biologics and medical devices. It also provides training, education, and legally-vetted marketing support to help its partners maintain compliance.
    GLOBAL
    GLOBAL is a full-service CRO specializing in complex biologics, drugs, medical devices, IVDs, & combination products. Its consulting support assists with determining the appropriate remediation plan and clinical strategy, which in turn helps clients save money long term.
    Biologics Consulting Group
    Biologics Consulting Group is a full-service regulatory and product development consulting firm for biologics, pharmaceuticals and medical devices. Founded in 1993, Biologics Consulting has become the go-to consulting partner for companies large and small seeking to bring innovative, safe and effective products to market within the U.S.
    Elexes Medical Consulting
    Elexes Medical Consulting provides a complete solution for all regulatory and quality systems requirements for Medical Device, SaMD, and IVD companies. Elexes was born to help Entrepreneurs, Medical Device, Drugs and Biologics Companies meet regulatory and quality standards, overcome regulatory hurdles, and stay in compliance.
    Emergo
    Emergo is a leading regulatory consulting firm specializing in global medical device and IVD compliance. Their comprehensive solution is designed to help achieve and maintain regulatory and commercial success. With a presence on six continents, they can provide real-time service and on-the-ground expertise.
    Johner Institute
    Johner Institute’s mission is to help medical device manufacturers overcome regulatory challenges and bring safe products to market faster. It offers consultancy, corporate services such as human factors studies and regulatory affairs support, as well as trainings (seminars, in-house, online).
    Regulatory Solutions, Inc
    Regulatory Solutions, Inc. has been ensuring that businesses become fully compliant with all regulatory guidelines for their medical devices. They also assist them with registering their facilities with different regulatory agencies as well as prepare and submit applications for all kinds of required certificates in an effective and efficient manner.
    RQM+
    RQM+ is the world’s largest regulatory and quality consulting firm focused on medical devices and diagnostics. They deliver transformative solutions to customers by providing unrivaled collective knowledge and expertise, fueled by their passion for customer success. Their experts are collaborative, laser focused on customer needs, and committed to delivering high-value solutions for both medical devices and diagnostics that exceed expectations.