Top Medical Device Testing and Certification Companies - 2022
The Importance of Independent Safety input into The Medical Devices R&D Process

Top 10 Medical Device Testing and Certification Companies - 2022

Medical technology and innovation are booming like never before. The unforeseen onset of the COVID-19 decelerated the breakthrough strides of the medical devices sector, but even amidst the pandemic, the rise of ground-breaking devices continued to revolutionize care delivery. Today, medical device manufacturers and healthcare service providers find themselves in a tight spot due to the emergence of complex regulatory requirements and ever-evolving customer needs. They face the challenge of introducing new and improved products to the market while adhering to the highest quality standards and regulations, which is driving the need for testing and certification partners that can reliably ensure product compliance and enable faster go-to-market times.

As one of the most trending medical devices, wearables undergo a plethora of tests like electromagnetic compatibility (EMC) or specific absorption rate before they are verified and validated for use. Manufacturers must also ensure that their wearables meet the stringent safety, quality, and performance standards set by regulatory entities. Another key aspect gaining significance in the current medical device marketplace is packaging. Firms working to package medical devices have to ensure that products have accurate labeling that displays their information for use. For consumer-based devices, packagers have to pass a series of FDA-mandated certifications and testing to ensure compliant and effective protection from environmental variables.

In this edition of MedTech Outlook, we present to you some of the most promising medical device testing and certification companies. The edition features thought leadership articles from Myriam Curet, Executive Vice President and Chief Medical Officer at Intuitive, Joe Kimura, Chief Medical Officer at Atrius Health, and Mike VanDerwerken, Director of Pharmacy at Saratoga Hospital. The edition also showcases innovative testing service providers, including WCG Imaging, which offers comprehensive services to support of Phase I-IV clinical trials and Class I, II, III medical device trials.

    Top Medical Device Testing and Certification Companies

    WCG Imaging
    WCG Imaging has become the world leader in medical imaging for AI and CAD trials. WCG Imaging is part of WCG, the world’s leading provider of solutions that measurably improve the quality and efficiency of clinical research. Comprised of two divisions, the industry’s first central IRB—WCG IRB—and first clinical services organization, WCG enables biopharmaceutical companies, CROs, and institutions to advance the delivery of new treatments and therapies to patients, while maintaining the highest standards of human participant protection.
    Biomedical Device Consultants and Laboratories
    Biomedical Device Consultants and Laboratories (BDC Laboratories) offers testing services and products to the medical device industry that aid in the mechanical and functional evaluation of medical device technologies as they relate to clinical outcomes. For over 35 years, BDC has been providing testing services and test instruments to aid with research and development.
    Charles River Laboratories
    Charles River Laboratories are passionate about their role in improving the quality of people’s lives. Their mission, excellent science and strong sense of purpose helps to improve the health and well-being of many across the globe. They offer the most comprehensive, integrated portfolio of drug development products and services available from a single global provider, spanning the continuum from early research to the support of marketed products.
    DDL, Inc.
    DDL, Inc. has provided package, product and material testing for the medical device industry for over 30 years. DDL’s testing services evaluate the strength and integrity characteristics of a packaging system before and after simulating the anticipated distribution and storage conditions that the system may undergo, including shock testing, vibration testing, tensile testing, leak testing, thermal performance testing, transit testing and validation services.
    iuvo BioScience
    iuvo BioScience is a contract research organization serving the pharmaceutical and medical device industries. With a focus on safety and biocompatibility, iuvo provides assistance through the full product development life cycle, from research to release, including ISO 10993:2018 testing as well as testing programs and advisory services to support regulatory submissions. The company is certified to ISO 13485:2016 and accredited to ISO 17025:2017 quality system standards.
    MED Institute
    MED Institute offers a variety of clinical trial services and are a full-service Contract Research Organization (CRO) with 35 years of experience designing and executing clinical trials, ranging from early feasibility studies to multinational, controlled pivotal trials to post-market registries. They offer medical device development services at every stage of the product development lifecycle.
    North American Science Associates
    North American Science Associates (NAMSA) is the world’s leading MedTech Contract Research Organization (CRO) offering global end-to-end development services. Driven by its global regulatory expertise and in-depth therapeutic knowledge, NAMSA is dedicated to accelerating medical device product development, offering only the most proven solutions to move clients’ products through the development lifecycle efficiently and cost-effectively.
    NTS
    NTS is the undisputed leader in testing, inspection, and certification. With the world’s top technical experts, NTS is able to simulate any climatic condition on earth and beyond. NTS has extensive experience supporting the invasive and non-invasive medical products market. For the reliability, precision, and durability to help keep patients and users safe, NTS adheres to a higher standard.
    Sanbor Medical
    Sanbor Medical is a contract manufacturer operating exclusively in the medical industry. They help medical device companies reduce production costs of finished devices or subsystem assemblies so they can better cope with increasing cost pressure from hospitals, insurance companies, and government regulations. With unique hybrid model, the company supports their customers’ business growth in both the United States and emerging markets.
    SGS
    SGS is the world’s leading testing, inspection and certification company recognized as the global benchmark for quality and integrity. Their testing and certification services reduce risks, shorten time to market and test the quality, safety and performance of products against relevant health, safety and regulatory standards and ensure that products, processes, systems or services meet national and international standards and regulations.