Physio-Logic Ltd.

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 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

Company’s Keywords:

quality assurance, regulatory affairs, software quality assurance, verification, validation, preclinical bench, animal, clinical trial research, medical device education & training center, medical device