Physio-Logic offers accelerated medical device compliance and certification solutions.
Headed by Gadi Ginot, it provides 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, privacy and HIPPA compliance, Agile
-Pre-Clinical Research - GLP Audits, full-service management of animal studies
-Clinical Affairs - full-service clinical trial solution  
-Education - in-house custom-made training and courses on regulation
 
Our carefully selected multi-disciplinary team includes M.Ds, Quality Engineers, Former FDA and Notified Body members, Toxicologists, Regulatory professionals, Lead QMS auditors with 10-30 years’ experience each.
 
Our Value Added:
-Winning regulatory strategies  
-We do it right the first time
-Hands-on - we get the job done for you
-On time and on budget
-All the know-how in one place


Physio-Logic Ltd.

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Physio-Logic Ltd.

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