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NDA Partners: World-Class Product Development And Regulatory Services

Top 10 Medical Device Testing and Certification Companies - 2019

Manufacturers of medical products, devices, components, and service providers today find themselves in a tough spot in the wake of complex regulatory requirements and changing customer needs. The challenge for them boils down to bringing new and improved products to the market as quickly as possible while adhering to the highest quality standards and all relevant global regulations. An essential aspect of this extensive process involves independent certification of products, processes, and quality management systems. These certification procedures can open markets, and the right choice of certification can make all the difference to stay ahead of the competition.

The device labeling needs to cover all aspects of the products in question, while quality packaging is necessary to ensure that the device is delivered to the consumer or healthcare center in an efficient and untampered state. The increasing scrutiny of the FDA on the Information For Use (IFU) leads to the need for each medical device to be labeled and packaged carefully. New consumer-based products to be introduced in the market need to pass a series of certifications and testing to ensure that they are safe to use, and will function appropriately through the product lifecycle.

 The potentially life-saving medical devices tread the fine line between the appropriate utilization of the latest technology to ensure user benefit and careful evaluation of the same to prevent the misuse of personally identifiable information. The ever-increasing adoption of wireless technology in medical devices causes concern—regulators demand new and additional testing to keep up with changing device requirements. For example, the proliferation of the Internet of Medical Things (IoMT) has benefited patients and their families by enabling continuous health monitoring through wearable or insertable devices, but the technology comes with new regulatory compliance requirements. The right testing and certification service providers remain updated continuously about these changing requirements, making it a cakewalk for device manufacturers to meet regulations and introduce new and beneficial products to the market.

Top 10 Medical Device Consulting Companies - 2020
Top 10 Medical Device Consulting Companies - 2019

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Top Medical Device Testing and Certification Companies

EdgeOne Medical

 EdgeOne Medical

EdgeOne Medical supports the entire medical device development process besides serving as a testing provider. Leveraging the company’s services including their ISO 13485 certified and FDA compliant quality management system and onsite testing laboratory, many global medical device and biopharma firms have gained success. The firm functions as an expert in cross-functional product development and work as an extension of the client’s team. The company performs testing services besides supporting product development initiatives of Biopharma companies

www.edgeonemedical.com

F2 Labs

F2 Labs

An accredited regulatory testing laboratory with more than 25 years of experience in performing EMC and safety evaluations on an extensive range of products, F2 Labs partners with its clients to make the world a safer place through efficient testing operations, exceptional customer service, and quality testing focused on attention to detail. F2 Labs' facilities are ISO/IEC 17025 accredited by the American Association of Laboratory Accreditation (A2LA), which is an ILAC signatory. Their reports are accepted worldwide by certification organizations including various Notified Bodies, OSHA accredited NRTLs, and more

f2labs.com

UX Firm

UX Firm

The company is a usability research consulting company engaged in formative and summative usability testing, human factors validation testing for medical devices and other types of UX research with clients present all over the globe. As a renowned medical device consulting companies, UX Frim is a one-stop shop for usability testing and UX consulting services, providing a full portfolio of user experience research tools to fit the needs of the client’s project. Whether it’s gathering, development, pre-launch, or post-launch, UX Frim provides the right UX tool or set of research tools to build the user experience into effective product designs

uxfirm.com

Analytical Lab Group

Analytical Lab Group

Analytical Lab Group (ALG) specializes in specialty contract lab space, with FDA- and EPA-focused laboratories across the United States, with facilities in San Francisco, Minneapolis, and Boston. The comprehensive testing solutions in the antimicrobial, pharmaceutical, medical device, biotech, and healthcare spaces have enabled the ALG team to uphold its principle of protecting life by preventing infection. Founded in the year 2017, the company is based in Eagon, MN, and employs a team of committed experts in the field. ALG facilities are FDA registered, GLP/GMP compliant, FDA registered, ISO/IEC 17025:2017 accredited, and A2LA approved

EAG Laboratories

EAG Laboratories

EAG Laboratories is an established name in the contract research and testing landscape. The global scientific services company operates at the junction of science, technology, and business. The team of scientists and engineers at the EAG Laboratories leverage multi-disciplinary expertise and advanced analytical techniques to resolve complex issues. The company possesses an unparalleled understanding of the physical structure, chemical properties, and performance of advanced materials and integrated circuitry, bolstered by its expertise, diverse analytical techniques, and technical ingenuity. EAG Laboratories utilizes its robust capabilities to assist its customers in accelerating innovation, ensuring quality and safety, and protecting their intellectual property

Element Materials Technology

Element Materials Technology

Element specializes in testing, inspection, certification, and calibration. It promotes safety, quality, and compliance by offering a comprehensive range of robust services to the global aerospace, transportation, fire, oil & gas, and infrastructure industries. The company operates on five continents, assisting customers in developing the best products in the market, minimizing time, cost, and risk associated with the materials and product development process. Based in London, Element employs over 6700 experts in 189 laboratories who make sure that the materials and products tested, inspected, certified, and calibrated for the customers are safe and compliant

Eurofins

Eurofins

Eurofins Scientific is dedicated to the environment, food, and pharmaceutical products testing and in agro-science CRO services. It also extends its expertise in certain laboratory and testing services for genomics, forensics, discovery pharmacology, advanced material science, and for supporting clinical studies. Moreover, it is an emerging player in speciality clinical diagnostic testing in the USA and Europe. Eurofins provides a portfolio of over 200,000 analytical methods for evaluating the identity, safety, composition, origin, authenticity, and purity of biological products and substances. The group aims to supply its customers with accurate results and high-quality services on time

FasTest

FasTest

FastTest manufactures valves and quick test connectors that enhance productivity, efficiency, profitability, and productivity for the compressed Gas Industries, Industrial Manufacturing, and HVAC-R. It will use its sealing expertise and connection to spot opportunities where it can help the customers to produce more profitable and efficient products. Owing to its core engineering skills FasTest has secured around 50 US and International patents. The patents act as the design platform for innovative products that enable the customers to improve their manufacturing process, testing, and productivity

Freyr Solutions

Freyr Solutions

Freyr is a full-service global Regulatory Solutions and Services Company that supports medium, large, and small size global Life sciences companies. It provides end-to-end Regulatory services across top 20 global firms for 6 of the Forbes Global Top 10 Fortune 500 Life Sciences/Healthcare, mid-market $1+ billion biopharma, Fast-growing life science, and several small-medium companies, Standards agencies and CROs. It is one of the rare entities to have pioneered specialized centers of excellence (CoEs), thereby contributing to the entire Regulatory value-chain that is supported by fast-growing global teams of 600+ regulatory professionals

Medical Device Testing Services

Medical Device Testing Services

Medical Device Testing Services (MDTS) is a specialist in automated examination and materials characterization of therapeutic tools. Medical Device Testing Services (MDTS) is American Association for Laboratory Accreditation's (A2LA's) biggest certified medical device inspection corporation with more than $5 million in business fatigue and durability testing solutions, inspection tools and inventory screening. Founded in 1990, the Medical Device Testing Services has been meeting the most demanding test requirements in the business per Food and Drug Administration (FDA), CE, American Society for Testing and Materials (ASTM), and International Standards Organization (ISO) guidelines

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