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
Company Details
- Employees
- 35
- Founded
- -
- Address
- 18 Haroshet Street, 10,israel
- Industry
- Medical Equipment Manufacturing
- NAICS
-
Medical Equipment and Supplies ManufacturingSurgical and Medical Instrument ManufacturingSurgical Appliance and Supplies ManufacturingDental Equipment and Supplies ManufacturingOphthalmic Goods ManufacturingDental Laboratories
- Website
- physio-logic.co.il
- Keywords
- Quality Assurance, Regulatory Affairs, Software Quality Assurance, Verification & Validation, Pre-Clinical (bench & animal), Clinical Trial Research, Medical Device Education and Training Center, Medical Device.
- HQ
- Ramat Hasharon, Israel
Physio-Logic Ltd. Questions
Physio-Logic Ltd.'s website is physio-logic.co.il
Physio-Logic Ltd.'s LinkedIn profile is https://il.linkedin.com/company/physio-logic-ltd-2019
Physio-Logic Ltd. has
35 employees.
View email and phone details for 35
employees at Physio-Logic Ltd..
Physio-Logic Ltd.'s industry is
Medical Equipment Manufacturing
Physio-Logic Ltd.'s top competitors are
Valcare Medical,
Pi-Cardia,
Magenta Medical Ltd.,
Gsap,
Eitan Medical,
Eurofins | Li-Med,
Memed,
Art Medical Ltd.,
Medinol,
Novocure.
Physio-Logic Ltd.'s categories are Medical Equipment Manufacturing
Physio-Logic Ltd.'s founding year is 2005
