Saturday, September 23, 2023
Saturday, September 23, 2023

Allmed Becomes the 1st Fully MDR Compliant Haemodialysis Product Producer in Europe, the Middle East and Africa (EMEA) Region

Allmed Medical GmbH, part of Allmed Group (“Allmed” or “the Company”), 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’s haemodialysis products in Europe.

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.

Ahmed Sorour, Chief Executive Officer at Allmed Group, said: “Allmed’s mission is to make a meaningful difference to people living on dialysis and receiving MDR certification means that we will continue to do so. Becoming the first fully compliant haemodialysis product producer in the EMEA region is a testament to our commitment to delivering high quality, safe solutions to haemodialysis patients, and I am proud of the many months of hard work and commitment by Allmed’s Total Quality Management team.”

Haydar Jaafar, Operations Delivery Director at BSI, commented: “We 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.”

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’s dialysis portfolio:

Hollow fibre haemodialyzer “POLYPURE® Family sterilized by Steam and Gamma”
Hollow fibre haemodialyzer “BIOREMA® Family sterilized by Steam and Gamma”
Arterial Venous Bloodlines “Sterilized by Gamma and ETO”
Sodium Bicarbonate Cartridge “Non-sterile product”
Dialysis Cleaning/Disinfection Cartridge “Non-sterile product”
Infusion Set “Sterilized by Gamma and ETO”

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.

Medical Device News Magazine
Our publication is dedicated to bringing our readers the latest medical device news. We are proud to boast that our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall purpose and objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

More News!

Lipogems® Announces 140 Independent Peer Reviewed Publications with 5 Years of Follow up in Orthopaedics

Giorgio Ninzoli, President of Lipogems International. "The gold standard for evidence is 1 year follow up and we are excited to report 5 years follow up with positive results after a single injection of MicroFat."

Stryker’s Triathlon Tritanium Baseplate Marks a Decade of Positive Patient Impact

Marking its 10th anniversary, the Triathlon Tritanium baseplate is designed with Stryker Orthopaedic Modeling and Analytics (SOMA) and enabled by Stryker's proprietary additive manufacturing technology.

Medtronic Diabetes Announces CE Mark for New Simplera™ CGM with Disposable All-in-one Design

The company's newest Simplera™ CGM is 50% smaller than its previous generation with a simple insertion and improved user experience

Study Outcomes Could Provide Insights Into New Targeted Treatments to Manage this Challenging Disease

The study aims to determine if immediate biological preservation of patient-derived chordoma tumor tissue, collected intraoperatively and implanted for serial sampling in translational research, will provide new insights into the biological weakness of the disease and contribute to developing improved treatment therapies reports NICO.

Henkel Joins with MedTech Europe to Drive Innovation In the Medical Technology Industry

Henkel has a long history of supporting the medical technology industry with its advanced adhesive and surface solutions. Through this, Henkel and MedTech Europe will collaborate on various initiatives such as supporting research and development projects, driving thought leadership and engaging in industry forums.

By using this website you agree to accept Medical Device News Magazine Privacy Policy