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PROVIDING INTERNATIONAL MEDICAL DEVICE

REGULATORY, QUALITY SYSTEM AND CYBERSECURITY CONSULTING SERVICES  

 

REGULATORY STRATEGY AND SUBMISSIONS – EUA BREAKTHROUGH – 510k – PMA – COMPLEX SOFTWARE INCLUDING AI/ML – MOBILE APPS – CYBERSECURITY – IVDs NEXT GEN SEQUENCING – AUDITS – TRAINING – U.S. FDA  ISO 13485 – MDSAP – EU MDR – EU IVDR

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