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Think it’s easier to launch in Europe with a CE Mark and get FDA clearance later? Then you’ll want to attend http://medgroup.biz/New-CE-Marking-Rules, a free webinar we’re hosting for group members on October 6. The latest adopted draft says you’ll need clinical trials for implantable and Class III devices (there are exceptions; tune in for those). The proposed modifications are a big deal. Getting your Notified Body to accept your device as “equivalent” may not be enough. TUV SUD’s Dr. Bassil Akra will discuss how you’ll need to adjust for EU medical device approval and post-approval processes. Sign up at http://medgroup.biz/New-CE-Marking-Rules and we’ll make the replay, slides, and transcript available for all who register. If you do business in Europe, you won’t want to miss this event. ++++++++++ 13485 Glitch If you registered for next week’s 13485 webinar but didn’t get a confirmation, please try again at http://medgroup.biz/ISO-13485-webinar because I found a software glitch that affected a few dozen subscribers. And if you haven’t registered, do it quickly because we already filled 759 seats. We’re hosting this event with greenlight.guru because the new ISO 13485 standard expects you to apply risk management methods and techniques to every single one of your QMS process, including outsourced processes as well. That link again: http://medgroup.biz/ISO-13485-webinar ++++++++++ Discussions How can you get listed on an incubator supplier directory? EC-REP change of address – what are the challenges? We can’t afford an FDA that discourages new, low risk medical technology What’s new in customer complaints? Med Device Companies: Never Say “We Sell Boxes” Legal requirements for marketing a Class I device in Germany LED Medical Devices in the EU ++++++++++ Make it a great week. Joe Hage Joe Hage Medical device manufacturers are challenged by several other requirements when they are applying for CE Marking. Which requirements did you find to be the most challenging? Joe Hage Joe Hage If you have a moderate risk device you probably will submit a 510(k) before applying for CE Marking, because some of the requirements for a technical file are more challenging than European requirements. Risk Management File 1. compliant with ISO 14971:2007 instead of EN ISO 14971:2012 Burrell (Bo) Clawson Joe Hage Burrell (Bo) Clawson Vivian Bui Joe Hage Vivian Bui Carlos Romero Marie Suetsugu CE Marking: 3 Biggest Challenges for US Companies Andrew Nelson Cheers, Joe Hage Andrew Nelson Anas Shokor Marcus Gould Clinical data and its evaluation, for all classes of medical devices, is especially being scrutinized here in the EU, and the notified bodies are really tightening up on the clinical requirements. No doubly Dr. Akra will introduce the following, but these three MEDDEV guidance documents on clinical evaluation and clinical investigations are being followed to the letter by the notified bodies and competent authorities: It is essential manufacturers of all medical device classes who intend to affix the CE mark to their device(s) understand these MEDDEVs in detail, and apply them according to the device class. Marked as spam
 Posted by Asked on September 22, 2015 2:05 am
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