Physio-Logic Ltd.

Physio-Logic Ltd.

Medical Equipment Manufacturing

Ramat Hasharon עוקבים, Israel 5,216

Israel largest vendor, providing accelerated medical device approval, certification and regulatory compliance solutions

ראו מקומות תעסוקה מעקב

עלינו

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

אתר אינטרנט
http://physio-logic.co.il/
תעשייה
Medical Equipment Manufacturing
גודל החברה
11-50 עובדים
משרדים ראשיים
Ramat Hasharon, Israel
סוג
בבעלות פרטית
הקמה
2005
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