7-layers-frees-manufacturers-of-wireless-health-care-products-from-regulatory-tangles

November 19th, 2008

7layers frees manufacturers of wireless health care products from regulatory tangles

At the Medica 2008 in Düsseldorf, Germany, 7layers presents its Regulatory Test Services, Certification and Bluetooth® Qualification Services for Medical Devices
Manufacturers of wireless health products, implementing wireless modules into their devices have to follow strict rules for testing, certification and labeling such as the Medical Devices Directive for example.

Test and certification requirements
In addition to this wireless health products have to be treated like radio devices. They must follow country specific, regulatory and type approval demands, like e.g. the R&TTE directive.
Depending on the technology in use, products also have to meet the requirements of specific qualification and certification regimes of the wireless industry. When integrating for example a certified or Bluetooth® qualified module, certain re-testing and further certification might be necessary.

Get your device to market with a minimum of test-effort
7layers offers testing, certification, Bluetooth® qualification and global type approval.
Manufacturers can rely on our technology know-how regarding radio technologies like GSM, GPRS, UMTS, EDGE, HSPA, Bluetooth®, W-LAN, WiMAX…
Short range devices like wireless blood pressure meters, remote controls etc. are our daily business. We help manufacturers to bring their wireless devices onto the market with a minimum of test-efforts but with a maximum of security regarding the necessary regulatory and certification requirements.

Meet 7layers at the Medica 2008 in Duesseldorf
Meet us in Hall 15, at the Bluetooth® SIG Pavilion, Stand No. C48 and find out how we can help you get your wireless health care products to market fast and efficiently.

7layers