Others

Services for rehabilitation and nursing-care products

TUV-SUD Product Service implements safety testing of rehabilitation and nursing-care products according to the International Standards/European Standards and also performs certification services for the Personal Protective Equipment Directive (PPE: 89/686/EEC). In Japan, as with CE marking for medical devices, these services are provided to you through the MHS Department of TUV-SUD Japan.

FDA 510 (k) Third-party Review Services

TUV-SUD Product Service was accredited as a third-party review organization for the FDA 510 (k) pilot program. These services will drastically shorten the time required to obtain 510 (k), as they eliminate the need for the time-consuming Phase 1 (technical review) after the application of 510 (k) to FDA. These services are invaluable for rapid access to the U.S. market.

For further details, refer to the linked page.