ADN enables MedTech companies to comply with ISO and FDA requirements.
We provide consulting for the Medical Device and In-Vitro Devices Lifecycle management :
ISO 13485:2016 /IEC 62304 / ISO 14971 / FDA 21 CFR Part 11 & Part 820

We can also help you reduce paper work with preconfigured, cost effictive software solutions to implement the following processes :
– Document control
– DHF / DMR
– CAPA / NCRs / Complaints
– Global Market Registration, Submissions and UDI