• List of Medical Devices Lab Testing Companies: Our Top 11 Picks

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    Medical Devices Testing Lab
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    Product compliance is essential when importing or manufacturing medical devices, including face masks, medical gloves, and other products. Verifying medical device compliance requires the involvement a of qualified third-party testing company.

    In this guide, we’ve listed 11 lab testing companies in the United States, Europe, and Asia, offering a wide range of testing and certification services for medical supplies.

    SGS

    SGS is one of the world’s largest testing and certification companies. The company offers testing, certification, training, and auditing services for medical devices against EU and other product safety regulations such as the Medical Devices Directive, the In Vitro Diagnostic Regulation, the FDA Medical Device Single Audit Program (MDSAP), the PMD Act (Japan), and others.

    Also, SGS provides testing services for medical face masks according to the following standards:

    a. EN 14683 – Requirements and Test Methods for Medical Face Masks

    b. ASTM F2100 – Standard Specification for Performance of Materials Used in Medical Face Masks

    c. AS 4381 – Single-use Face Masks for Use in Health Care

    In addition, SGS also provides testing services for other medical devices like nitrile gloves, surgical gowns, and electro-medical equipment.

    Covered Products

    • Face masks
    • Medical gloves
    • Medical gowns
    • Electro-medical devices

    Services

    Company Information

    • Year of Registration: 1878
    • Locations: US, UK, EU, China, Korea, Japan

    HQ Address: 1 Place des Alpes, P.O. Box 2152, 1211 Geneva 1, Switzerland

    TÜV Rheinland

    TÜV Rheinland helps businesses in the medical devices field with testing and certification according to local regulations around the world.

    TÜV Rheinland mainly provides testing services for medical devices in the US, Canada, Australia, China, Japan, Brazil, Russia, and other countries.

    Covered Products

    • Medical face masks
    • Infrared thermometers
    • Class I, II and III medical devices
    • Electro-medical devices

    Services

    • Medical Devices Regulation testing (EN Standards)
    • Medical Devices Regulation notified body
    • FDA testing (ASTM standards)
    • ISO 13485 certification
    • PMD Act registration (Japan)
    • ANVISA product registrations (Brazil)
    • GOST R certification (Russia)

    Company Information

    • Year of Registration: 1872
    • Locations: US, Canada, Australia, China, Japan, Brazil, and Russia

    HQ Address: Am Grauen Stein 29, 51105 Köln, Germany

    Intertek

    Intertek offers medical equipment and medical devices testing solutions and clinical research services.

    These services cover a wide range of medical devices, whether it be FDA Class I low-risk devices, a Class II infusion pump, or Class III surgical laser equipment in the US, as well as other types of medical devices in Europe, Japan, China, and South America.

    Particularly, Intertek offers comprehensive testing services for face masks and medical gloves according to EN, ASTM, NIOSH, ISO, and GB standards as the following:

    a. ASTM F2100-19 – Standard Specification for Performance of Materials Used in Medical Face Masks

    b. NIOSH CFR Part 84 Requirements for Respiratory Protective Devices

    c. EN 14683 Requirements and Test Methods for Medical Face Masks

    d. GB 32610 Technical Specification of Daily Protective Mask

    e. ASTM D5250 Standard Specification for Poly(vinyl chloride) Gloves for Medical Application

    Covered Products

    • Medical gloves
    • Medical face masks
    • Hospital beds
    • Infrared thermometers
    • Surgical, cosmetic, therapeutic and diagnostic laser equipment
    • Ultrasound devices

    Services

    • Medical Devices Regulation testing (EN Standards)
    • Medical Devices Regulation notified body
    • IEC 60601-1-2 EMC services for medical devices
    • RoHS 2 services for medical devices
    • FDA testing (ASTM standards)

    Company Information

    • Year of Registration: 1880
    • Locations: US, UK, China, Japan

    HQ Address: 33 Cavendish Square, London, W1G 0PS, United Kingdom

    Eurofins

    Eurofins provides regulatory consultation and testing services for medical devices in accordance with the EU and US regulations across 20 laboratories in North America, Europe, and the Asia Pacific, covering medical devices like FFP Class / N-Series masks, protective respirators, gloves, face shields, and medical gowns.

    Covered Products

    • Masks and protective respirators
    • Face shields
    • Gloves
    • Gown and drapes

    Services

    • Medical Devices Regulation testing (EN Standards)
    • Medical Devices Regulation notified body
    • FDA testing (ASTM standards)
    • Penetration of synthetic blood testing for mask
    • GMP/GLP/ISO 17025 testing certification

    Company Information

    • Year of Registration: 1987
    • Locations: US, UK, Canada, China

    HQ Address: Val Fleuri 23, 1526, Luxembourg

    UL

    UL provides medical device third-party regulatory approvals, product testing, certification, and auditing services to manufacturers, suppliers, and importers.

    These services cover products like surgical masks, protective goggles, face shields, surgical gowns, gloves, and other medical products according to the EU, North America, and Australian standards.

    Among the others, they cover the following standards:

    a. ASTM D6319 – Standard Specification for Nitrile Examination Gloves for Medical Application

    b. ANSI Z87.1 – Eye Protection

    c. NIOSH – Requirements for Respiratory Protective Devices

    d. 21 CFR 878.4040 Requirements for Surgical apparel

    Covered Products

    • Surgical, medical masks
    • Filtering facepiece respirators
    • Protective goggles
    • Face shields
    • Isolation gowns
    • Medical gloves

    Services

    • Medical Devices Regulation testing (EN Standards)
    • Medical Devices Regulation notified body
    • FDA testing (ASTM standards)

    Company Information

    • Year of Registration: 1894
    • Locations: US, Canada, UK, Australia, China

    HQ Address: 333 Pfingsten Rd, Northbrook, Illinois, United States

    QIMA

    QIMA was founded in 2005 in Hong Kong as a provider of safety lab testing, quality inspections, supplier audits, and product certification to manufacturers, and private brands. The medical devices testing services provided by QIMA include products such as face masks, gowns, and gloves.

    In addition, QIMA is a HOKLAS accredited testing lab and offers a wide range of tests for protective eyewear products against many applicable international and national standards, including ISO, EN, ANSI, GB, and AS/NZS standards.

    Covered Products

    • Medical face masks
    • Medical gloves
    • Medical gowns
    • Medical goggles

    Services

    • Medical Devices Regulation testing (EN Standards)
    • Fiber content analysis

    Company Information

    • Year of Registration: 2005
    • Locations: Hong Kong

    HQ Address: Sino Plaza 8th Floor, 255-257 Gloucester Road, Causeway Bay, Hong Kong S.A.R

    DDL

    DDL is an ISO 17025 accredited laboratory headquartered in Eden Prairie, Minnesota, with branch offices in California and New Jersey, offering medical devices testing services for the past 30 years.

    DDL’s testing services cover products like face masks, ventilators, medical gowns, medical and examination gloves, needles, surgical sutures, syringes, and other devices for surgical and medical uses.

    The following are examples of standards DDL tests to:

    a. EN 14683 Requirements and Test Methods for Medical Face Masks

    b. ASTM F2100 Standard Specification for Performance of Materials Used in Medical Face Masks

    c. ASTM D3578 Standard Specification for Rubber Examination Gloves

    d. ASTM D5250 Standard Specification for Poly(vinyl chloride) Gloves for Medical Application

    Covered Products

    • Surgical masks
    • Filtering facepiece respirators
    • Protective goggles
    • Face shields
    • Isolation gowns
    • Medical gloves

    Services

    • Medical Devices Regulation testing (EN Standards)
    • FDA testing (ASTM standards)

    Company Information

    • Year of Registration: 1989
    • Locations: US

    HQ Address: 10200 Valley View Road, Eden Prairie, Minnesota, United States

    Element

    Element provides quality assurance advisory and testing services to medical devices, including protocol development, feasibility trial testing, and consultation for 510(k), and CE marking.

    Element’s services covered general medical devices such as medical masks, medical gowns, and face shields.

    The following are available testing standards at Elements:

    a. EN 14683 – Requirements and Test Methods for Medical Face Masks

    b. ASTM F2101 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials

    c. CAN/ULC-S109-03 Flame Tests of Flame-resistant Fabrics and Films for Medical Gowns

    d. ANSI/ISEA Z87.1-2020 Requirements for Personal Eye and Face Protection Devices

    Covered Products

    • Face masks
    • Face shields
    • Protective goggles
    • Isolation gowns
    • Hand sanitizers

    Services

    • Medical Devices Regulation testing (EN Standards)
    • Medical Devices Regulation notified body
    • Chemical Compatibility Testing for Medical Devices and Materials
    • Cardiovascular Device Testing
    • Microbiological Analysis

    Company Information

    • Year of Registration: 1827
    • Locations: UK, US, Canada

    HQ Address: 161 Bay Street Suite 3600 Toronto, Ontario, Canada

    Eurolab

    Eurolab is a Turkish lab that provides material analysis and product testing services in accordance with European, ASTM, and Turkish standards, covering products like medical devices, jewelry, wooden products, baby products, and packaging.

    Covered Products

    • Face masks
    • Respirators
    • Filtering facepiece respirators
    • Protective goggles
    • Face shields

    Services

    • Medical Devices Regulation testing (EN Standards)
    • Microbiological and chemical tests

    Company Information

    • Year of Registration: 1990
    • Locations: Turkey, UK, Germany, France

    HQ Address: Merkez Mah, Dr. Sadik Ahmet Cd, No. 38/44 D Bağcılar, Istanbul, Turkey

    Hong Kong Standards and Testing Centre (STC)

    Hong Kong Standards and Testing Centre (STC) was established in 1963 in Hong Kong. STC provides third-party lab testing, inspection, and certification services to manufacturers, and importers.

    The company is accredited by the Hong Kong Laboratory Accreditation Scheme (HOKLAS), the German Accreditation Service (DAKKS), and the CNAS (China National Accreditation Service for Conformity Assessment).

    STC’s medical devices testing services cover standards applied in the EU, US, and Australian markets, such as:

    a. EN 14683 Requirements and Test Methods for Medical Face Masks

    b. ASTM F2100 – Standard Specification for Performance of Materials Used in Medical Face Masks

    c. ANSI Z87.1 Eye Protection

    Covered Products

    • Medical face masks
    • Medical gloves
    • Safety goggles
    • Protective clothing

    Services

    • Medical Devices testing
    • Electrical Testing for Medical Devices
    • ISO 13485 Certification

    Company Information

    • Year of Registration: 1963
    • Locations: Hong Kong, Japan, Vietnam, US, Germany

    HQ Address: 10 Dai Wang Street, Tai Po Industrial Estate, Tai Po, New Territories, Hong Kong

    Biomedical Device Consultants and Laboratories

    Biomedical Device Consultants and Laboratories offers lab testing services to medical devices in the United States. The company is situated in Colorado and has more than 30 years’ experience in the general R&D field of medical device testing covering medical devices Class I, II, and III.

    Biomedical Device Consultants and Laboratories mainly offers mechanical testing services to surgical operation devices and systems such as the implant, endovascular system, and delivery system.

    Covered Products

    • Face masks
    • Medical gloves
    • Medical gowns
    • Catheters

    Services

    • General Medical Devices Testing
    • Vascular Graft Testing
    • Catheter Testing

    Company Information

    • Year of Registration: 1977
    • Locations: US

    HQ Address: 4060 Youngfield St, Wheat Ridge, Colorado, United States

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