Our current project, LiverforLife (aka Apersys AG), has successfully completed the first stage of the ISO 13485 audit 👏 This marks a first step towards full certification of the startup's internal #qualitymanagement system and #compliance with global best practices. Full certification, requiring a stage two audit, will fortify the startup's position within the marketplace. See below for more info about the successful stage one audit 👇 #ISOCertification #MedTechInnovation #StartupSuccess #QualityStandards #RegulatoryCompliance #BusinessExcellence #MedicalDevices
Apersys Successfully Completes Stage 1 ISO 13485 Audit, Paving the Way for Full Certification PRESS RELEASE Zurich, Switzerland – October 2nd, 2024 – Apersys, an innovator focusing on organ transplantation, proudly announces the successful completion of its Stage 1 BSI audit, a critical milestone on the path to full ISO 13485:2016 certification. This achievement underscores Apersys' unwavering commitment to upholding the highest standards in quality management and operational excellence. The Stage 1 audit, conducted by the British Standards Institution (BSI), thoroughly examined Apersys' management system, processes, and readiness for the upcoming Stage 2 audit. Passing this preliminary stage validates the documentation of the company's internal quality management system and compliance with international best practices. “We are delighted to have successfully passed our Stage 1 audit,” said Waldemar Hoffmann, CEO of Apersys. “This accomplishment highlights our dedication to continuous improvement and ensuring that our clients receive products and services that meet the highest global standards.” The next step in the certification process is the Stage 2 audit, where Apersys will be further evaluated on its implementation of the ISO standards. Achieving full certification will enhance Apersys' position in the marketplace and reinforce its commitment to delivering quality and trust to its customers and stakeholders. A big round of congratulations goes to Evgenia (Jenny) Papafotopoulou Patrinou, Apersys Quality Manager and Dawn Balazs-Metz, Senior Consultant and ad interim Management Representative, from @meditec, thankfully consulting Apersys. Both were instrumental in driving the significant documentation and organization required to achieve this important milestone. About Apersys AG At Apersys, we create the best possible environment for the liver outside the human body. Our research shows the promise of ultra long-term perfusion for liver preservation. This is critical because almost a third of patients are left untreated due to a lack of viable transplantable organs. Additionally, our perfusion platform technology paves the way to accelerate translational research. The company is committed to excellence and adheres to the highest standards of quality and safety. For more information about Apersys AG and our development, please visit our website at apersys.com. About Meditec We provide regulatory and quality consulting services throughout the entire product life-cycle. When your company needs to define a regulatory strategy, create a dossier, or prepare for a FDA inspection or ISO audit, meditec Consulting brings in 20 years of experience in the pharmaceutical and device environment to support your project. Our customers range from start-ups, SMEs to global players. We aim at providing you with a clear understanding of the requirements and support you with their efficient and practical implementation.