UL Launches New Compliance Package for Medical Device Manufacturers

Underwriters Laboratories Inc. has launched a regulatory compliance program designed for medical device manufacturers. UL’s affiliate notified body can assess and document the manufacturer’s claim of compliance. The program includes UL’s services enabling manufacturers to secure access to the European Union, North America, Asia, and Latin America, in local languages.

“Manufacturers can more quickly gain clearance of their products for market entry and take advantage of the recognized and accepted UL mark for key markets,” said Harvey Rudolph, PhD, program manager of medical devices.

The program includes: U.S. FDA 510(k) reviews, notified body service for CE marking, CMDCAS service for Canada, the INMETRO Mark for Brazil, testing and certification for Japan, and ISO 13485 certification. The service provides combined audits for EU market access, follow-up safety inspections for the United States, and management system certification by a local project team.

For more information, visit www.ul-vip.com or call Melanie de Leon at 847-664-1967.

Northwest EMC Opens Southern California Facility

Northwest EMC has completed construction of its Irvine, CA, facility, which was specifically designed and constructed to house large certification chambers. The 20,000-sq-ft facility contains a 10-m FCC-listed anechoic chamber, a 3-m FCC-listed anechoic chamber, and two additional 3-m chambers. One of the 3-m chambers is used for precompliance testing and the other is dedicated to immunity testing.

The facility is listed with Industry Canada for wireless devices. The scope of the new lab includes BSMI and AS/NZS standards as well.

The company expects to increase its emissions capabilities from 18 to 40 GHZ and immunity from 4 to 18 GHz or higher and from 40 to 100 V/m or higher.

For more information, go to www.nwemc.com.

TUV America Inc. Introduces an ESD S20.20 Certification Service and Expands its Product Safety Testing Group

TÜV America Inc. is now certified to perform ANSI/ESD S20.20 certification services. ANSI/ESD S20.20, the Electrostatic Discharge Control Program Standard, provides guidance for designing and maintaining an ESD control program. The standards addresses the following activities related to handling electrical or electronic parts, assemblies, and equipment susceptible to damage by electrostatic discharges greater than or equal to 100 V human body model. Such activities include: manufacturing, processing, assembly, installation, packaging, labeling, service, testing, and inspection.

ANSI/ESD S20.20 certification proves to customers, suppliers, and competitors that an organization has an effective ESD control program in place and that it has been certified by a third party. TÜV America, an accredited ISO 9001 registrar, is one of six registrars that can perform S20.20 certification.

The company has also expanded its product safety program with the addition of three new product safety engineers to its machinery, information technology, and consumer products (MIC) group.