Qmed Consulting A/S Logo - medical devices

Qmed Consulting A/S

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

Qmed Consulting A/S is a global Contract Research Organization (CRO) and consultancy firm based in Copenhagen, Denmark. Founded in 2006 by Helene Quie, the company specializes in the medical device sector, focusing on enhancing patient well-being through clinical investigations and studies related to medical devices and In Vitro Diagnostic (IVD) products. Qmed is certified with ISO 9001 and ISO 14155, demonstrating its commitment to quality and regulatory compliance. The firm offers a wide range of services, including clinical trial management, regulatory affairs consultancy, quality assurance, market access, and reimbursement strategies. Qmed supports clients throughout all stages of medical device projects, providing tailored solutions such as technical documentation and regulatory compliance assistance. Their team consists of experienced professionals with expertise in medical device approvals and clinical research standards, aimed at facilitating the approval of innovative medical devices and improving healthcare outcomes. Qmed primarily serves medical device and IVD companies seeking expert guidance in their regulatory and market access efforts.

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Keywords
commercial healthcare medical device cro strategic consutling eu authorized representative training clinical affairs regulatory affairs concept design development biostatistics medical writing concept amp design development market access quality management medical equipment manufacturing clinical investigation design clinical trial protocol development clinical trial safety monitoring risk management pre-market studies clinical trial documentation clinical trial data analysis performance validation clinical studies quality assurance mdr standards healthcare innovation clinical investigation planning clinical trial reporting regulatory documentation regulatory strategy
Company Information
  • Employees 39
  • Founded 2006
Location

53 Kobmagergade, Kobenhavn, Capital Region of Denmark, Denmark, 1150

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