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Scott Levy, Expert in Medical Device Packge Testing Compliance and Regulation
Scott Levy
Packaging Engineer
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Mr. Scott Levy has been the lead packaging sales engineer at DDL for the last twelve years. He is responsible for training and managing five other sales engineers throughout the United States. He takes responsibility to work one on one with clients to ensure their packaging project complies with industry standards and regulations the first time.
He specializes in ISO 11607 and also has an extensive background in shock and vibration testing that crosses all barriers in a vast number of industries.
He is an industry leader in educating medical device manufactures and has spoken on medical device package testing at a number of industry events. He has been published in industry magazines including Pharmaceutical & Medical Packaging News, Healthcare Packaging and Medical Design Technology.
He’s Vice President of the Medical Device Resource Group (MDRG), a coalition of Twin Cities-based companies that together offer the broad expertise needed to successfully develop and market a medical device. Scott is also a member of ASTM and IoPP.
Scott received an Industrial Technology Degree, with a concentration in packaging, from the University of Wisconsin, Stout.
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How could the use of consensus standards that are recognized by the FDA in their Guidance documents entitled "Recognition and Use of Consensus Standards" be helpful in developing a package system and obtaining a PMA or 510(k) appoval?
Using a consensus standard aids the medical device manufacturer since “conformance with recognized consensus standards can support a reasonable assurance of safety and/or effectiveness for many applicable aspects of medical devices. Therefore, information submitted on conformance with such standards should have a direct bearing on safety and effectiveness determinations made during the review of IDE’s, HDE’s, PMA’s, and PDP’s.”. The Guidance further indicates that, “if any premarket submission contains a declaration of conformity to the recognized consensus standards, this declaration should, in many cases, eliminate the need to review the actual test data for those aspects of the device addressed by the standard”. So, using recognized consensus standards could speed the product approval process and/or aid in the successful FDA audit of the package design and validation process.
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