Physio-Logic Ltd.
Own or work here?
Contact Listing Owner
Contact Now!
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
How Many Employees Does This Company Have?
33
Which Industry Does This Company Belong To?
medical devices
What Is the Annual Income?
What Is the Technology of All the Company’s Website?
Outlook, Amazon AWS, Mobile Friendly, Varnish, Google Tag Manager
What Year Was the Company Founded?
2005
Rate us and Write a Review
