Regulatory Testing from Start to Certificate

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    Case Studies

    Case Studies

    Discover our clients' regulatory compliance challenges, and the outcomes which we helped them to achieve
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    Merck & Co., Inc. is an American multinational pharmaceutical company headquartered in Rahway, New Jersey, and is named for Merck Group, founded in Germany in 1668, of whom it was once the American arm. The company does business as Merck Sharp & Dohme or MSD outside the United States and Canada.
    Segment
    Healthcare
    Challenge:
    Multi transmitters wearable product under development not design to meet compliance
    Outcome:
    CE-RED, FCC, ISED, GMA market surveillance
    The company pioneered the portioned coffee segment, now the most dynamic and fastest-growing in the global coffee market. Nespresso is at the forefront of this evolution, with sales in 80 countries worldwide and a global network of more than 700 boutiques.
    Segment
    Home Appliance
    Challenge:
    GMA & National deviations research to support R&D for a product under development
    Outcome:
    Safety design Implementation & Compliance plan
    The company pioneered the portioned coffee segment, now the most dynamic and fastest-growing in the global coffee market. Nespresso is at the forefront of this evolution, with sales in 80 countries worldwide and a global network of more than 700 boutiques.
    Segment
    Home Appliance
    Challenge:
    Certification for an auxilary product connected to Nestle product which has been stocked in the custom due to missing certification
    Outcome:
    CE
    Emerson Electric Co. is an American multinational corporation headquartered in Ferguson, Missouri. The Fortune 500 company manufactures products and provides engineering services for industrial, commercial, and consumer markets.
    Segment
    Industrial
    Challenge:
    Family products with many variants
    Outcome:
    GMA certification for various countries
    "Bosch is a German multinational engineering and technology company headquartered in Germany. Bosch’s core operating areas are spread across four business sectors: mobility (hardware and software), consumer goods (including household appliances and power tools), industrial technology (including drive and control) and energy and building technology."
    Segment
    Industrial
    Challenge:
    Implementaion of new RED requirements
    Outcome:
    CE-RED Type Examination
    The 3M Company, formerly known as the Minnesota Mining and Manufacturing Company, is an American multinational conglomerate corporation operating in the fields of industry, worker safety, health care, and consumer goods.
    Segment
    IoT
    Challenge:
    Family products with many variants
    Outcome:
    Cost reductions and faster time to market
    Nvidia (Mellanox) is an multinational supplier of computer networking products based on InfiniBand and Ethernet technology. Nvidia (Mellanox) offers adapters, switches, software, cables and silicon for markets including high-performance computing, data centers, cloud computing, computer data storage and financial services.
    Segment
    Telecom
    Challenge:
    Certification Buttlenack which cause delay in the supply chain
    Outcome:
    ISO17025 accredited lab under A2LA
    Align Technology is a manufacturer of 3D digital scanners and clear aligners used in orthodontics. It is headquartered in San Jose, California; it manufactures the aligners in Juarez, Mexico and its scanners in Israel and China.
    Segment
    Healthcare
    Challenge:
    FDA 510K comments
    Outcome:
    FDA
    Biosense Webster the science and the technology behind the diagnosis and treatment of cardiac arrhythmias, Biosense Webster pioneered the CARTO® 3 System, an advanced imaging technology that creates real-time, 3D maps of a patient’s cardiac structures, helping electrophysiologists better navigate the heart.
    Segment
    Healthcare
    Challenge:
    Lack of knowledge in R&D vs. stanadrds requirements
    Outcome:
    Training and database tools

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