medical devices

engineering

equipment, processes and utilities

From user requirements to qualification, production and operations
Engineering study of the phases of Concept Engineering – Basic Engineering – Detail Engineering :
Commissioning
Production support and continuous improvement

R&D

medical device R&D

Our expertise is in the main types of medical devices :
Our skills :

qualification / validation

equipment, processes and utilities

Quality support for R&D or production
Standards environment: ISO 13485, ISO 14971, ISO 62366, 21 CFR Part 820, etc
Regulatory Affairs :
Postmarket surveillance :

clinical operations

Altogen helps its clients manage and run their clinical studies, by supplying staff in the following areas :

vigilance

We support our partners in pharmacovigilance, cosmetovigilance, medical device vigilance and nutritional vigilance in the detection of signals and the explanation and prevention of adverse incidents.

For this purpose, our employees work in areas such as MedDRA coding, entering cases into databases, processing adverse incidents and drafting periodical reports (PSUR/DSUR) for our clients.

We are hiring :