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Published: Tuesday, September 27, 2005 - 22:00 “As a former Japanese In-Country CareTaker, TÜV has the experience and knowledge to help customers navigate through Japan’s unique requirements,” says John Bier, TÜV America medical products director. “Our auditors have passed a stringent PAL training program and qualifying exams that allow us to perform a single, comprehensive audit which can result in multiple regulatory certifications for our clients.” TÜV America will also host a series of Webinars discussing the PAL. The Webinars will provide clients with an overview of the system, licensing requirements, QMS requirements, reporting requirements and more. It will be offered Oct. 21, Oct. 25 and Oct. 26. TÜV America is a testing/certification organization that provides CE marking assistance, mechanical/electrical product safety, electromagnetic compatibility (EMC), field evaluations, NRTL and SCC certification. For more information, visit www.tuvamerica.com. Quality Digest does not charge readers for its content. We believe that industry news is important for you to do your job, and Quality Digest supports businesses of all types. However, someone has to pay for this content. And that’s where advertising comes in. Most people consider ads a nuisance, but they do serve a useful function besides allowing media companies to stay afloat. They keep you aware of new products and services relevant to your industry. All ads in Quality Digest apply directly to products and services that most of our readers need. You won’t see automobile or health supplement ads. So please consider turning off your ad blocker for our site. Thanks, For 40 years Quality Digest has been the go-to source for all things quality. Our newsletter, Quality Digest, shares expert commentary and relevant industry resources to assist our readers in their quest for continuous improvement. Our website includes every column and article from the newsletter since May 2009 as well as back issues of Quality Digest magazine to August 1995. We are committed to promoting a view wherein quality is not a niche, but an integral part of every phase of manufacturing and services.TÜV America Offers Certification Services to New Japanese Pharmaceutical Affairs Law
TÜV America recently announced its ability to offer medical device certifications to the new Japanese Pharmaceutical Affairs Law (PAL). Effective since April 1, PAL monitors how medical devices are marketed and regulated in Japan. It regulates and classifies medical devices by their level of risk. It also affects in vitro diagnostics reagents, medicines, toiletry products and cosmetics. The certifications will be offered by TÜV Japan Ltd., which is a subsidiary of TÜV SÜD Group, as is TÜV America. TÜV Japan Ltd. is accredited to assess all categories and in vitro diagnostic reagents.
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