Meet the team of Experts
Regulatory Strategy
Clinical Evaluations
Clinical Studies
Notified Body Introductions
Regulatory (Europe, FDA, Asia & Latin America)
(1)Regulatory Strategy & Device Classification
(2)PRRC
(3)Authorized Representative Support & Set-up
(4)Importing
(5)EUDAMED Registration & Data Maintenance
(6)Technical Documents – Gap assessments
Risk Management – ISO 14971
Quality (ISO 13485, MDSAP, eQMS set-up, Auditing, Supply Chain & Distribution)
(1)Quality Policy and Manual
(2)QMS procedure implementation & validation
(3)QMS integration – Assistance for merges and acquisitions
(4)Auditing
Usability Studies (Animal, Cadaver & Simulated -use experiments)
Particulate testing of medical devices
Post-Market Surveillance
Project Management
Quality Management Systems (ISO 13485, MDSAP, FDA, MDR, IVDR eQMS set-up & Auditing)
(1)Quality Policy and Manual
(2)QMS procedure – implementation & process validation
(3)QMS integration – Assistance for merges and acquisitions
(4)CAPA Management & Non-conformities
(5)Complaint Handling – Vigilance/MDR
(6)Auditing
Regulatory (Europe & FDA)
(1)Regulatory Strategy & Device Classification
(2)PRRC
(3)Authorized Representative Support & Set-up
(4)Importing
(5)EUDAMED Registrations & Data Maintenance
(6)Labelling
(7)Change control
(8)Product registration, Listing & GUDID
(9)Letters to File
(10)Technical Documents – Gap assessments
Risk Management – ISO 14971
Supplier Qualification & Management
Post-Market Surveillance
Project Management
Biological Safety
Toxicological Risk Assessment
Gap Assessments – Changes related to Design, Manufacturing, Location, Material and intended use changes.
Material Safety & Hazardous Substances
Failed Biocompatibility testing evaluation
Particulate testing of medical devices
