Norman Noble, Highland Heights, OH, has added dedicated staff to its Quality team to support the critical needs of customers supplying the European market. Quality Assurance Resources provide support for meeting the new European Union Medical Device Regulation requirements, such as chemical reporting and conflict mineral reporting.
This includes “Regulation (EU) 2017/745 on Medical Devices” which became effective on May 26, 2021. “NNI recognizes the importance of efficient and accurate chemical content reporting to customers,” said David Saletrik, director of quality assurance at Norman Noble. “The NNI Quality Assurance Group has staff trained and assigned to respond to (EU) 2017/745 requests in additional to the related REACH, (EC 1907/2006), RoHS 3 Directive (2015/863), California Proposition 65 Act, and other related regulations.”
Formal Documentation of Medical Device and Medical Device Component cleanliness has become increasingly critical to Norman Noble’s customers’ regulatory compliance and new product approval needs. In response, Noman Noble operates and maintains a final cleaning process validated in accordance with ASTM F3127-16 in addition to select customer product cleanliness requirements. The validation strategy defines a series of robust tests which incorporate various raw material types (stainless steel, titanium Nitinol, PEEK, etc.) and their resulting cleanliness after being exposed to processing material and chemicals.
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