Intelliger Consulting

Intelliger Consulting is a specialized life sciences consultancy providing regulatory affairs and quality management services to medical device, in vitro diagnostic (IVD), and pharmaceutical companies. The firm assists clients with the implementation and maintenance of Quality Management Systems (QMS) in compliance with international standards such as ISO 13485 and FDA 21 CFR 820. Their expertise is particularly focused on navigating the complex regulatory landscape of the European market, including the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). Additionally, they provide support for clinical evaluations, technical documentation, and internal auditing to ensure market access and ongoing compliance. The company serves a global clientele, helping them streamline the path from product development to commercialization.