AKRA TEAM

medical devices

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.

Technologies

Outlook Microsoft Office 365 WordPress.org reCAPTCHA Apache Mobile Friendly Remote

Keywords

medical equipment manufacturing eu ivdr consulting global regulations medical devices iso 14971:2019 regulatory compliance usability regulatory affairs performance evaluation eu mdr drug-device-combination templates healthcare risk management other scientific and technical consulting services annex xvi devices b2b cybersecurity vigilance system regulatory consulting quality management systems udi clinical evaluation clinical performance studies technical documentation services post-market surveillance derogation art 97 clinical investigation education

Location

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

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