Medical Device Testing and Certification
HTW Lab can guide you through the testing process step by step for your medical device products, and help you meet regulatory standards for global market access. For technical regulation support, technicians at HTW are able to help you understand technical regulations and product design specifications.
We are experienced in supplying one stop service for globe market access such as NMPA, FDA, CE-MDR, CE-IVDR, CMDCAS, ANVISA, Biocompatibility/ISO 10993 Testing. Communicate with our experts to determine your needs and we will provide you with an evaluation, proposal and quotation.
We offer a rang of testing and certification solutions for All medical devices including emerging technologies and devices such as MedTech, HealthTech, BioTech, AthleticTech and Wareables.
Moreover, our team of experts with years of experience are able to provide full-service testing and certification solutions for wireless medical devices like remote patient monitoring devices. Our medical device solutions cover a wide range of aspects from the design and development stages through manufacturing and end products.
HTW Lab, accredited by CNAS, CMA, consistently operates competently and generates accurate and valid results in accordance with ISO/IEC 17025. Our lab meets the requirements of GLP. We can supply test service in accordance with national and global standards for both active and non-active medical products. Our familiarity with these standards makes for a seamless and trustworthy testing process, and a full range of biocompatibility testing capability according to ISO 10993 .
Thus, testing reports from HTW Lab can be accepted between countries.
HTW Testing and Certification Solutions.
FDA Registration: medical device manufacturers registered with FDA
FDA Listing: medical devices listed with FDA
Note: Registration of a device establishment, assignment of a registration number, or listing of a medical device does not in any way denote approval of the establishment or its products by FDA. Contact us to learn more about FDA Registration Fees.
Owners or operators of establishments that are involved in the production and distribution of medical devices intended for use in the U.S. are required to register annually with the FDA. Generally, establishments that are required to register with the FDA are also required to list the devices that are made there and the activities that are performed on those devices. If a device requires a premarket submission before being marketed in the U.S., then the owner/operator should also provide the FDA premarket submission number (510(k), De Novo, PMA, PDP, HDE).
Registration and listing provide the FDA with the location of medical device establishments and the devices manufactured at those establishments. Knowing where devices are made increases the nation’s ability to prepare for and respond to public health emergencies.
1. Provide us with product pictures, product brochures/manuals
2. Determine your needs（test report purpose/target market）
3. Receive the testing/compliance service proposal and quotation
4. Sign contract and make payment
5.Send samples (please contact us for address info.)
6.Informed project opening and test TAT(turn around time) via email
8.Draft report for your confirmation
9. Formal reports endorsed by ILAC - CNAS (electronic version)
10.Sample Discard or Return
Patient Monitoring Devices Testing
Wireless Medical Device Testing
Cardiovascular Device Testing
Orthopedic Implant Testing
Mechanical Testing of Materials in Devices and Packaging
Chemical Analysis for Medical Device Components
Medical Device Packaging Validation
Healthcare and Medical Testing Services
Class I, II, and III Medical Devices Testing and Certification
Biological Evaluation Of Medical Devices
Medical Device Materials Testing
Biocompatibility Testing for Dental Materials
Physical Testing of Medical Devices and IVD Equipment
Electrical Safety Testing (IEC 60601-1)
EMC Testing for Medical Devices
Functional Safety Testing of Medical Devices
IECEE CB Scheme
Wireless Testing for Medical Devices
In Vitro Diagnostic Medical Devices Testing