We are ISO 13485 certified medical device consulting company. Active since 2012 currently present in Italy, Switzerland, UK, Shanghai and opening in Boston soon.
We provide wide range of service:
– MDR transition (including Clinical Evaluation, Biological evaluation, Risk Man, GSPR, Sted, etc…)
– EUAR, Swiss AR, UKCA\n- ISO /MDSAP Auditing Service
– IQ/OQ/PQ and GAMP5 Validations
– eIFU Smart tools
– US Submissions
– EUDAMED and International Registration
– Staffing and Training of Personell