Aurevia Medtech Compliance (formerly QAdvis) Logo - medical devices

Aurevia Medtech Compliance (formerly QAdvis)

medical devices
China's Best One-Stop Medical Equipment Provider
About

Aurevia Medtech Compliance, formerly known as QAdvis, is a European company dedicated to enhancing healthcare, pharmaceuticals, and medical technology development. It focuses on regulatory compliance, quality assurance, and clinical research. Formed in January 2025 through the merger of several organizations, Aurevia operates in Sweden, Finland, Germany, and Poland, serving customers in over 60 countries. As a full-service Contract Research Organization (CRO), Aurevia offers a wide range of services. These include regulatory affairs and quality assurance, where they guide medical device and IVD manufacturers through complex regulations. They also provide extensive clinical research services, supporting various phases of development for pharmaceuticals, biotech, medical devices, and IVDs. Additionally, Aurevia offers external quality assessment services to help clinical laboratories maintain high analytical performance and meet quality standards. Their expert consultants engage actively with industry networks, ensuring they stay at the forefront of evolving standards in healthcare.

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Keywords
medical device regulations ce marking fda & qsr mdr ivdr ivdd mdd iec 62304 iso 13485 iec 623661 software clinical evaluation sted regulatory quality uk responsible person europeanauthorizedrepresentative due diligence iso 14971 performance evaluation risk management software as medical device usability medical equipment manufacturing iec 60601 product design software validation market surveillance other scientific and technical consulting services legal
Company Information
  • Employees 30
  • Founded 2013
Location

33 Faeroegatan, Stockholm, Stockholm County, Sweden, 164 51

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