Top Regulatory and Compliance Companies - 2022
Maxis Medical: innovating Medical Device Development

Top 10 Regulatory and Compliance Companies - 2022

Every medical device manufacturing company seeks to innovate through iterative updates to existing technology or by developing new devices that could offer a more effective treatment for a particular disease or condition. However, constantly changing regulatory affairs add a critical bottleneck throughout a medical device’s product lifecycle. Notably, medical device regulatory and compliance companies are playing a crucial role in this regard, from planning pre-market strategy and drafting regulatory submissions to ensuring post-market compliance.

Supporting their endeavor, artificial intelligence (AI) and machine learning (ML) technologies are helping in extraction and analysis of a massive amount of data to seamlessly traverse through the complex processes of the FDA’s pre-market to post-market approval pathway.

Besides, the regulatory professionals are also utilizing AI and ML to implement strategies that bolster against increasing cybersecurity threats and data breaches. This is further being accompanied by government support. For instance, the FDA has collaborated with the U.S. Department of Homeland Security to improve information sharing and collaboration to address cybersecurity risks, including less secure communication as well as prevention of unauthorized access when it comes to data transfer to and from the device.

At this juncture, there is variety of regulatory and compliance companies that are entering the market to cater to the different needs in the medical device regulatory and compliance domain. To choose the regulatory and compliance company that best fits medical device manufacturer’s requirements, MedTech Outlook has compiled this edition. Besides, the magazine also comprises insights from thought leaders in the sector on the industry trends, best practices, recent innovations, and their advice for aspiring CIOs.

We present to you MedTech Outlook’s, “Top 10 Regulatory and Compliance Companies – 2022.”

    Top Regulatory and Compliance Companies

    DuPont Co. legacy Expert-Nation.com Pioneered
    Expert-Nation.com is the DBA (doing business as) blend of CECON.com Science, Engineering, and Technical Experts, founded in 1985 by a half dozen DuPont Co scientists and engineers who were among the first to accept its “early-out” downsizing offer(s), and SamWaltz.com Strategic Capital & Business Counsel, founded in 1993 by a senior-level DuPonter who is a global and national leader in strategic business advisory and capital services. Now in its 3rd generation ownership and management, as a Vietnam-era U.S. Military Veteran-owned firm, the firm’s Managing Director Sam Waltz headed Public Affairs and Corporate Affairs for DuPont’s Medical Products Department in the early 1990s.
    GAB Consultancy
    GAB Consultancy guides medical device manufacturers and OEMs to simplify their audit processes and shorten their ISO certification timeline. GAB Consultancy starts its partner engagement with both a gap analysis and a preliminary internal audit to assess the client’s specific roadblocks in attaining compliance to the requirements of various ISO standards. GAB Consultancy then develops the initial quality management system documentation by incorporating all the policies, processes, and procedures following alignment with ISO requirements, and in alignment with their existing workflows. At this time GAB Consultancy additionally generates the organization’s quality manual which serves as a top-level document outlining the ISO compliant quality management system.
    MAXIS Medical
    MAXIS Medical’smission is to provide strategic and operational expertise in clinical market development, resulting in successful pre-clinical development, first-in-man, CE mark, and post-market studies. At each stage, its goal is to achieve continued increase in the valuation of an emerging medical company. Working with a client’s senior management, we develop programs and manage projects that shorten time to market, expedite product adoption, and accelerate market penetration of new medical treatments.
    Boulder iQ
    Boulder iQ is an expert contract consulting firm providing all the services a life science company needs to get its product to market. With years of experience in regulatory, quality, product development, manufacturing and contract EO sterilization, their single-source solution speeds the product development and regulatory submissions process. Their experts help companies navigate through the process of getting medical device, diagnostic and combination products to the market quickly. Since 2009, Boulder iQ experts have helped companies navigate the process of getting medical device, diagnostic, and combination products to the market quickly.
    CBR International
    CBR International is a full-service global product development, clinical oversight, and regulatory operations group providing comprehensive "lab to launch" program development services. They serve the biotechnology, pharmaceutical, and device industries worldwide. Their expert staff is experienced in an all-encompassing range of indications for drugs, novel antibodies, recombinant protein therapeutics, small molecules, vaccines, cell therapy, devices, and combination products, throughout all phases of program development (Phases I - IV) and commercialization. Their teams have the expertise to support the client projects over their entire lifetimes, all the way from preclinical development through approval and post-marketing.
    evo820
    evo820 was founded by dental industry professionals to provide dental laboratories a practical and affordable pathway to regulatory compliance through a implementation of a Quality Management System that is specifically designed for the CAD/CAM dental laboratory. It provides a variety of FDA Reguletory Compliance consulting services and resources to help every company and organization effectively and effiecently reach their goals. They provide the expertise to obtain the US FDA 510(k) clearence for companies wanting to distribute medical devices in the United States. It audits QMS to assure that the clients are prepared for the FDA Inspection and have all documents in order.
    Operon Strategist
    Operon Strategist is a medical device regulatory consulting company which provides regulatory advisory and guidance to various manufacturers in the healthcare industry to ensure the strategic development of these manufacturers. They serve clients by providing turnkey services, system implementation, training, licensing, regulatory approvals and certifications in addition providing a complete turnkey solution to manufacturers looking to set up a world-class manufacturing unit. They also provide customized packages as per the requirements of the client. Their global presence caters to clients from around the globe & includes small start-ups to world’s renowned medical device manufacturers. Their team of expert's knowledge & experience helps them handle clients both small and large. As a trusted partner to their clients, they strive to provide services within budget, agreed on timeline and to the highest quality standards in order to exceed expectations.
    Paladin Medical
    Paladin Medical, Inc offers a full range of medical device regulatory, clinical, and technical services for FDA and international premarket applications. They provide bedrock training and procedure templates to assure regulatory compliance as the product is developed and company evolves.They have the hands-on engineering, development, and executive management experience that not all regulatory consultants can offer. They work with clients to define the best regulatory approach for new products, helping companies small and large to develop premarket submissions, and clinical studies supporting all aspects of premarket applications.
    Xinetix
    Xinetix advances medical products for startups and established companies through incubation ideation, design, development, and advisory. From idea to reality, their vision to improve and perfect every aspect of project is founded in a passion to better life through every project we touch. On the other side of better, success is achieved, lives are changed and health and well-being are improved; ensuring both clients and their patients experience.They enter each client relationship with the view of a stakeholder acting as an extension of the client organization and providing an exacting blend of vision, experience and resources to delight their customers.
    Bio-Med USA
    Bio-Med USA is one of the leading manufacturers of various FDA cleared Mediacal/Aesthetic/Surgical/Dental laser systems. They have been providing exceptional products for over 30 years, distributing both domestically and internationally. They provide guidance for 510(k) submission, ensuring the customers have all the information needed and to answer all questions. They have worked directly with FDA branch chiefs and reviewers, which translates into extensive product knowledge and industry experience passed on to customers throughout their 510(k) submission review.