Neujin Solutions

Neujin helps medical device manufactures to compliant with current regulatory requirements of different regulatory authorities. We are expert in medical device regulatory affairs, QMS, Clinical investigation and other requirements. Alceon was founded in the year 2019 and, within three years we have completed more than 50 projects in various type of medical devices as well as in vitro diagnostic devices and gain excellent reputation in market. Moreover, Alceon is certified by globally reputed certification body BSI for quality management system in the scope of providing regulatory consultancy services to medical device and IVDs manufacturer. We provides end to end support in regulatory consultancy in below listed area. 1) Indian MDR Test License Manufacturing license Import license Post approval 2) EU MDR Preparation of technical file Review of technical documents and gap analysis Risk Management of devices Post market surveillance Clinical Evaluation 3) USFDA Preparation technical file Review of technical documents and gap analysis Validation of technical file Primary correspondent 4) Health Canada 5)TGA Some other services like 1) ISO 13485 QMS Preparation Implementation Maintenance 2) Trainings on different topics related to medical device regulatory as well as QMS