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Physio-Logic offers accelerated medical device compliance and certification solutions. Headed by Gadi Ginot, it provides a hands-on, full service, synergistic solutions offering the best-in-class experts covering all aspects of medical device regulations. Our contract services include: -Regulatory Affairs - regulatory strategy, international medical device registration (FDA, CE Mark, CMDCAS, Far East, AMAR and more), remediation of compliance crisis -Quality Assurance - Leading certification and compliance GMP programs including ISO 13485:2016, MDSAP, FDA Inspections, internal audits, design V&V, process validation -Software Quality Assurance - testing and V&V to FDA and CE requirements, Sw lifecycle per IEC 62304, cyber security, privcau and...
Quality assurance,regulatory affairs,software quality assurance,verification & validation,pre-clinical (bench & animal),clinical trial research,medical device education and training center,and medical device
Physio-logic ltd operates in the Medical equipment manufacturing industry.
Physio-logic ltd's revenue is 11m - 100m
Physio-logic ltd has 11 - 50 employees.
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