Hemovent™ Receives MDSAP Certificate for United States and Canada

Aachen, Germany, 2 June 2022 – Hemovent GmbH (hereafter referred to as “Hemovent™”) has received a Medical Device Single Audit Program (MDSAP) certificate from the DQS Medizinprodukte GmbH (DQS), an international notified body. This certifies Hemovent™’s compliance with both ISO 13485:2016 standards and the regulatory requirements in the United States and Canada, laying groundwork for the company's future global development and growth.

Initiated by the International Medical Device Regulatory Forum (IMDRF), the MDSAP program is anchored in ISO 13485 and incorporates the regulatory requirements of five participating countries (the United States, Canada, Brazil, Australia, and Japan). It allows an MDSAP-recognized auditing organization to conduct a single audit of a medical device manufacturer that satisfies the regulatory requirements of all five countries. The MDSAP Certificate obtained by Hemovent™ covers two of the five countries (the United States and Canada) and certifies the design, development, production, service, and distribution of extracorporeal life support system products. Hemovent™ officially began the MDSAP audit process (for the United States and Canada) in August 2021 and passed the second stages of on-site audits by DQS in December 2021 and February 2022, before the MDSAP quality system certificate was issued by DQS in April 2022.

“We are proud to have internationally expanded full ISO 13485:2016 QMS certification, which demonstrates our ability to provide medical devices that consistently meet customer and applicable regulatory requirements,” commented by Christof Lenz, CEO of Hemovent, “Obtaining the MDSAP quality system certificate will pave the way for Hemovent™’s ambitious future expansion plans to international markets.”

Hemovent™’s quality management system is developed on the ISO 13485:2016 standard as the fundamental framework and incorporates national or regional regulatory requirements of target markets. To date, the system is compliant with relevant regulations and standard requirements of the European Union, the United States, and Canada.

About Hemovent™

Hemovent GmbH, based in Aachen, Germany (Hemovent™), a subsidiary and Innovation Lab of MicroPort Scientific Corporation (MicroPort®, stock code: 00853.HK), is a developer and manufacturer of highly innovative extracorporeal life support (ECLS) and extracorporeal membrane oxygenation (ECMO) products. Its flagship product, the MOBYBOX™ system, is the world’s first fully integrated and self-contained ECLS system for the treatment of cardiac and/or respiratory failure. It is extremely easy to use and surpasses all existing technologies in terms of size and transportability. Hemovent™ is committed to deliver best-in-class medical devices to save patients’ lives during severe cardiac or respiratory failure, which affect about 12 million people worldwide every year.