Physio-Logic Ltd. Information

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