{"id":28335,"date":"2022-06-15T11:19:12","date_gmt":"2022-06-15T06:19:12","guid":{"rendered":"https:\/\/pr.asianetpakistan.com\/?p=93392"},"modified":"2022-06-15T11:19:12","modified_gmt":"2022-06-15T06:19:12","slug":"allmed-becomes-the-first-fully-mdr-compliant-haemodialysis-product-producer-in-europe-the-middle-east-and-africa-emea-region","status":"publish","type":"post","link":"https:\/\/myanmarnewsgazette.com\/allmed-becomes-the-first-fully-mdr-compliant-haemodialysis-product-producer-in-europe-the-middle-east-and-africa-emea-region\/","title":{"rendered":"Allmed becomes the first fully MDR compliant haemodialysis product producer in Europe, the Middle East and Africa (EMEA) region"},"content":{"rendered":"<div>\n<p align=\"center\"><strong>Allmed becomes the first fully MDR compliant haemodialysis product producer in Europe, the Middle East and Africa (EMEA) region<\/strong><\/p>\n<ul type=\"disc\">\n<li><em>Compliance with EU <\/em><em>Medical Devices Regulation<\/em><em> (MDR<\/em><em> 2017\/745<\/em><em>) certified by<\/em><em> the<\/em> <em>British Standards Institution (BSI)<\/em><em> auditing body<\/em><\/li>\n<\/ul>\n<p align=\"justify\"><strong>LONDON, UK<\/strong><strong>; <\/strong><strong>15<\/strong> <strong>June<\/strong><strong>,<\/strong><strong> 2022<\/strong> \u2013 Allmed Medical GmbH, part of Allmed Group (\u201cAllmed\u201d or \u201cthe Company\u201d), a producer of end-to-end haemodialysis solutions, today announces that it has received Medical Device Regulation (EU MDR 2017\/745) certification from its Notified Body, the British Standards Institution (BSI), ensuring continuous market access of the Company\u2019s haemodialysis products in Europe.<\/p>\n<p align=\"justify\">With the certification, Allmed has become the first haemodialysis products producer in the EMEA region to accomplish and certify full MDR compliance on its medical devices.<\/p>\n<p align=\"justify\"><strong>Ahmed<\/strong> <strong>Sorour<\/strong><strong>, Chief Executive Officer<\/strong> <strong>at <\/strong><strong>Allmed<\/strong> <strong>Group<\/strong><strong>, said:<\/strong> <em>\u201c<\/em><em>Allmed\u2019s mission is to<\/em> <em>make<\/em><em> a <\/em><em>meaningful<\/em><em> difference <\/em><em>to<\/em> <em>people<\/em><em> living on dialysis and <\/em><em>receiving MDR certification<\/em><em> means that we will continue to <\/em><em>do so.<\/em><em> Becoming<\/em><em> the first fully compliant haemodialysis product producer in<\/em><em> the EMEA region is a testament<\/em> <em>to <\/em><em>our<\/em><em> commitment to deliver<\/em><em>ing<\/em><em> high quality, safe solutions to haemodialysis patients<\/em><em>, and I am <\/em><em>proud of<\/em><em> the<\/em> <em>many <\/em><em>months of hard work<\/em><em> and commitment<\/em><em> by Allmed<\/em><em>\u2019s Total Quality Management<\/em><em> team.\u201d<\/em><\/p>\n<p align=\"justify\"><strong>Haydar Jaafar<\/strong><strong>, <\/strong><strong>Operations Delivery Director<\/strong><strong> at BSI, commented:<\/strong> <em>\u201cWe are delighted to issue the essential MDR certificates to Allmed Medical GmbH, who have prioritised working to the new, more stringent MDR requirements. This achievement is a testament to their commitment to ensuring innovation remains at the forefront of their product development. These life-saving products will support patient safety at a critical time and are a sign of the resilience of our industry.\u201d<\/em><\/p>\n<p align=\"justify\">The certificate, valid until 2027, will be officially registered on the European Database of Medical Devices and covers the following product groups, which are major components of Allmed\u2019s dialysis portfolio:<\/p>\n<ol>\n<li>Hollow fibre haemodialyzer \u201cPOLYPURE\u00ae Family sterilized by Steam and Gamma\u201d<\/li>\n<li>Hollow fibre haemodialyzer \u201cBIOREMA\u00ae Family sterilized by Steam and Gamma\u201d<\/li>\n<li>Arterial Venous Bloodlines \u201cSterilized by Gamma and ETO\u201d<\/li>\n<li>Sodium Bicarbonate Cartridge \u201cNon-sterile product\u201d<\/li>\n<li>Dialysis Cleaning\/Disinfection Cartridge \u201cNon-sterile product\u201d<\/li>\n<li>Infusion Set \u201cSterilized by Gamma and ETO\u201d<\/li>\n<\/ol>\n<p align=\"justify\">Additionally, Allmed has successfully passed all MDR-related Quality Management System (QMS) audits and has been granted the corresponding certificate (BS EN ISO 13485:2016+A11:2021) valid until 2025.<\/p>\n<p align=\"justify\"><strong>About Allmed Group <\/strong><\/p>\n<p align=\"justify\">Allmed Group is a global producer of end-to-end haemodialysis product solutions. It is headquartered in London and has product development and manufacturing operations in Germany and in Egypt. In addition, it has direct sales, marketing &amp; distribution operations in the UK, Brazil, Egypt, Turkey, Poland, Germany and India. The Group employs more than 1,300 staff world-wide and exports to more than 40 countries across the globe.<\/p>\n<p align=\"justify\"><strong>About European Medical Device Regulation (MDR)<\/strong><\/p>\n<p align=\"justify\">The MDR 2017\/745 came into effect in May 2021, replacing the former European Directives for medical devices (AIMDD 90\/385\/EEC and MDD 93\/42\/EEC). It is intended to establish a robust, transparent, predictable and sustainable regulatory framework for medical devices to ensure a high level of safety and health whilst supporting innovation. EU MDR has significantly increased the requirements in respect of technical documentation, risk management approach, benefit-risk evaluation, Unique Device Identification (UDI), Economic Operators, clinical evaluation, vigilance, trend reporting and post-market surveillance, with more stringent scrutiny of Competent Authorities and Notified Bodies. It represents the biggest change in European medical device compliance standards in more than 20 years.<\/p>\n<p align=\"justify\">For further information, please contact:<\/p>\n<p><strong>Allmed Group<\/strong><br \/>\n<a href=\"https:\/\/www.google.com\/url?q=https:\/\/www.globenewswire.com\/Tracker?data%3Dx9nBrzra9XV4-HsUA6mvJywuWvcB-MNcS8hvjk8sZOveBRc6aOLQb-5gvQRhYIakEEVe-C4wBa1lZbyfidTA1fj5zrAPMdGeJxYuy7WgtzE%3D&amp;source=gmail-html&amp;ust=1655360324791000&amp;usg=AOvVaw1kMQGPg96gTl1D3A6oaOIh\"  rel=\"nofollow noreferrer\">info@allmedgroup.com<\/a><br \/>\nTel: +44-20-8899-6450<\/p>\n<p><strong>Consilium Strategic Communications <\/strong><br \/>\nMatthew Neal\/ Davide Salvi\/ Lucie Foster<br \/>\nTel: +44(0)20-3709-5700<br \/>\nEmail: <a href=\"https:\/\/www.google.com\/url?q=https:\/\/www.globenewswire.com\/Tracker?data%3DtKMowKq5I08cgoo39ir2FedTWGg2x5PiJwLAMrzioFt_lEGYweUlpDcy2bSipULxJ9eQ9Du3gjxH0ZuIjR-yT1ScMvRLhooZmUFS4fQazyxIMOJfkszDxLtMcXDxuwLM&amp;source=gmail-html&amp;ust=1655360324791000&amp;usg=AOvVaw2iQHnrtXaKnV6C_8TepQDt\"  rel=\"nofollow noreferrer\">allmed@consilium-comms.com<\/a><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Allmed becomes the first fully MDR compliant haemodialysis product producer in Europe, the Middle East and Africa (EMEA) region Compliance with EU Medical Devices Regulation (MDR 2017\/745) certified by the British Standards Institution (BSI) auditing body LONDON, UK; 15 June, 2022 \u2013 Allmed Medical GmbH, part of Allmed Group (\u201cAllmed\u201d or \u201cthe Company\u201d), a producer [\u2026]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[14],"tags":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v22.3 - 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