EMDT_European Medical Device Technology

European Medical Device Technology, Spring 2014

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emdt.co.uk European Medical Device Technology Spring 2014 | 45 nounced audits: If there is an outsourced process and this process is critical to the safety of the device or the patient, then a Notified Body has to make the decision to do an unannounced audit there, too, even if this contract manufacturer has a [quality management or ISO] certificate." Further complicating matters is the fact that contract manu- facturers and suppliers may be reluctant to acquiesce to unan- nounced audits. "I find that contract manufacturers have the hardest time with these things because up until today, they could hide; but, they can't hide anymore," Sarner said during her MD&M West presentation in response to an attendee's concern. "Because this is the direction it's going, [contract manufacturers] don't like it, but they know they have to be prepared for it. Even- tually, they're not going to push back like they are now." To be fair, however, some subcontractors and suppliers have a reason to be reluctant. Those suppliers that partner with numer- ous medical device companies may be stuck hosting a revolving door of auditors from different Notified Bodies. In addition to the constant disruption to normal operations, a string of unan- nounced audits may cause conflicts and added stress if different Notified Bodies show up at the same time to perform an unan- nounced audit. Furthermore, unannounced audits raise new questions relat- ing to intellectual property (IP), according to Havel. A contract manufacturer may not want its IP disclosed for the process or part provided to the manufacturer, for example. This is a point that may need to be addressed when revising contracts, he notes. The Impact of Unannounced Visits While device manufacturers serving the European market must now shoulder an additional burden, these measures will likely help to separate the wheat from the chaff. Companies prone to questionable quality processes or shortcuts are more likely to be discovered, and industry will be kept on its toes. "On one side, unannounced audits are a big burden," Havel says. "But there will be a strengthening of quality across the whole industry. Those manufacturers that are committed to qual- ity—and that is the majority—suffer because of corner cutters. [Companies that take shortcuts] will have huge problems in the future; any time they decide to produce in a different way than was certified or approved, there could be an auditor at the door ready to [expose] them." Companies prone to questionable quality processes or shortcuts are more likely to be discovered, and industry will be kept on its toes Connect with us at 1.949.448.7056 www.interfaceusa.com Balloon Development Balloon Manufacturing Precision Extrusion Weld Development Folding and Wrapping Development Swaging Development Your Balloon Catheter Manufacturing Offering the only transferable technology on the market Excellence in balloon catheter development and manufacturing can only be built on the mastery of a well spent 18 years building it. Visit us at MEDTEC Europe Stand 5F48 ES433887_EMDT1405_045.pgs 05.02.2014 14:04 UBM black yellow magenta cyan

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