China's Best One-Stop Medical Equipment Provider
About

AKRA TEAM is a consultancy company founded in 2021 by Dr. Bassil Akra, focused on supporting stakeholders in the healthcare system, particularly in the medical device, in-vitro diagnostic (IVD), and combination device sectors. The company aims to help innovators, manufacturers, notified bodies, and regulators navigate complex legal obligations to ensure the timely delivery of safe and effective medical products. With a team that boasts over 250 years of combined expertise, AKRA TEAM specializes in regulatory, quality, and clinical affairs. Their services include regulatory consulting, quality management support, clinical affairs documentation, auditing, and training. They also offer personalized consulting sessions and introductory meetings to address specific regulatory and quality questions. AKRA TEAM has offices in Germany and the USA, reflecting its international reach and commitment to facilitating compliance and market access for medical and diagnostic devices.

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Keywords
medical equipment manufacturingeu ivdrconsultingglobal regulationsmedical devicesiso 14971:2019regulatory complianceusabilityregulatory affairsperformance evaluationeu mdrdrug-device-combination templateshealthcarerisk managementother scientific and technical consulting servicesannex xvi devicesb2bcybersecurityvigilance systemregulatory consultingquality management systemsudiclinical evaluationclinical performance studiestechnical documentationservicespost-market surveillancederogation art 97clinical investigationeducation
Company Information
  • Employees19
  • Founded2021
Location

17A Am Penzinger Feld, Landsberg am Lech, Bavaria, Germany, 86899

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