BA

Bassil Akra

Chief Executive Officer

AKRA TEAM

Landsberg am Lech, Bavaria


Contact Information

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Company Information

Company
AKRA TEAM
Industry
medical devices
Employees
22.0
Seniority
C suite

Technologies

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Keywords

medical equipment manufacturing eu mdr quality management systems mdr technical documentation clinical evaluation clinical investigation pms requirements pmcf requirements sscp ivdr general requirements ivdr technical documentation technical documentation regulatory strategy risk management usability samd cybersecurity global regulations drug-device-combinations notified bodies market access post-market surveillance clinical performance studies risk analysis benefit-risk assessment conformity assessment regulatory compliance clinical evaluation report iso 14971 eu ivdr performance evaluation patient safety clinical evidence technical file essential requirements eu medical device regulation clinical trials stakeholder engagement gmp compliance quality assurance regulatory affairs market regulations device classification safety & effectiveness documentation standards training & support audit preparation risk control measures clinical investigation report device validation medical devices hospital & health care health care health wellness & fitness

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