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CELLIANT meets updated requirements for Class 1 Medical Devices in EU
September 28th, 2023
The European Union (EU) has upgraded the requirements for the Class 1 Medical Device designation and Hologenix®, creators of CELLIANT®, has met the stricter requirements for this important market. This means that compliant manufacturers can continue to use the CE mark on their EU products containing CELLIANT. Hologenix has been a trailblazer in achieving regulatory […]
The value and limitations of medical device master files
November 1st, 2019
by Elaine Duncan Medical device master files, known as MAFs, have value for textile contract manufacturers and the medical device developer in many ways, but there are some practical limitations. Most medical device manufacturers that incorporate a medical textile into their products will seek a knowledgeable textile contractor who can address the quality system needs […]