Darling Ingredients Launches Quali-Pure, a Range of Gelatins with Controlled Purity, Supporting Full Compliance with New Eu Medical Device Regulations and ISO 22442
October 19, 2021 at 08:00 am EDT
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Darling Ingredients Inc.'s launches Quali-Pure™, a range of gelatins for biomedical applications with controlled endotoxin levels. The latest addition to Rousselot Biomedical's rapidly expanding portfolio, Quali-Pure has been specifically designed for a variety of applications including embolization, wound healing, drug delivery, vaccines and hemostatics. Quali-Pure delivers biocompatibility, biodegradability, controlled endotoxin levels, and batch-to-batch consistency, and fully supports medical device compliance with ISO 22442 and the new EU Medical Device Regulation (MDR) standards. The Quali-Pure range of high-quality gelatins offers device manufacturers an endotoxin-controlled gelatin, that delivers the optimal functional properties, as well as meeting the standards required to comply with the enhanced regulatory requirements. Quali-Pure gelatins come with full traceability, documentation and viral safety. Medical device producers are facing increased safety requirements for biomaterials. From May 2024, all devices placed on the European market must conform with the new EU Medical Device Regulation (MDR). Regulation (EU) 2017/745 on Medical Devices (the MDR) has replaced the existing medical devices Directive (93/42/EEC) (MDD) and the active implantable medical devices Directive (90/385/EEC) (AIMDD). In addition, the ISO standard 22442 has been updated to bring it further in line with global requirements for medical devices.
Darling Ingredients Inc. develops and produces sustainable natural ingredients from edible and inedible bio-nutrients, creating a range of ingredients and customized specialty solutions for customers in the pharmaceutical, food, pet food, animal feed, industrial, fuel, bioenergy and fertilizer industries. Its segments include Feed Ingredients, Food Ingredients and Fuel Ingredients. Feed Ingredients operating segment includes its global activities related to the collection and processing of beef, poultry and pork animal by-products in North America, Europe and South America into non-food grade oils and protein meals, and others. Food Ingredients operating segment includes its global activities related to the purchase and processing of beef and pork bone chips, beef hides, pig skins, and fish skins into collagen, and others. Fuel Ingredients operating segment includes its global activities related to the conversion of organic sludge and food waste into biogas in Europe, and others.
Darling Ingredients Launches Quali-Pure, a Range of Gelatins with Controlled Purity, Supporting Full Compliance with New Eu Medical Device Regulations and ISO 22442