EMDT_European Medical Device Technology

European Medical Device Technology, Spring 2014

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emdt.co.uk European Medical Device Technology Spring 2014 | 43 But this confirmation of day-to-day com- pliance introduces a new set of challenges for Notified Bodies and medical device manufacturers alike. If auditors come unexpectedly knocking at a manufacturer's door, there's the chance that the necessary employees will be unavailable, on holiday, or out sick. In addition, while manufactur- ers should notify their Notified Bodies of periods when certified products will not be manufactured, there will also likely be mistakes, misunderstandings, or extenuat- ing circumstances that arise. The mandatory unannounced audits cer- tainly represent uncharted territory. That's not an excuse to be completely unprepared, however. "We expect industry to have com- petent staff to be able to deal with all of this stuff," Sarner said. "The way we look at it is that your quality management system and your company production need to be effectively implemented whether someone's out sick or not." To that end, it is imperative that medi- cal device manufacturers have a clear plan in place for what to do in the event of an unannounced audit. When auditors come knocking at the door, employees need to know how to reach necessary quality management and production personnel. Staff members, according to Havel, must be aware that an unannounced audit can and may happen, so that no one turns the auditors away, thereby jeopardizing the company's certificates. He adds that small and midsize companies, in particular, need an airtight plan because they run lean teams that may not have the luxury of having staff with overlapping or redun- dant qualifications. "If you look at it logically, if the system is in day-to-day compliance, the auditor should be able to walk in at any time," Havel says. "But how it is in practice is something we'll learn together with manu- facturers." Critical Subcontractors and Crucial Suppliers As if unannounced audits weren't nerve- wracking enough, the European Com- mission has further complicated the process by applying them to the supply chain. "Notified Bodies may, instead of or in addition to visiting the manu- facturer, visit one of the premises of the manufacturer's critical subcontractors or crucial suppliers if this is likely to ensure more efficient control," according to the recommendations. "This applies in particular if the main part of the design development, manufacturing, testing or another crucial process is located with the subcontractor or supplier." Moving forward, manufacturers must thus identify their critical subcontractors and crucial suppliers; these companies, in turn, will be subject to unannounced audits. Here's the rub: Manufacturers need to review and, if necessary, revise contracts ODU Connector Systems for Medical Technology High-End connectors for medical applications. • high mating cycles • autoclavable • anti-magnetic • high reliability • reliable touch protection • shielded www.odu.de Visit us in Hall 7, Stand C62, Stuttgart, 03. – 05. June 2014 ES430779_EMDT1405_043.pgs 04.29.2014 03:28 UBM black yellow magenta cyan

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