Neujin helps medical device manufacturers to compliant with current regulatory requirements of different regulatory authorities. We are expert in medical device regulatory affairs, QMS, Clinical investigation and other requirements. 

Neujin 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, Neujin 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 provide 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

Neujin Solutions Pvt.Ltd

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Neujin Solutions Pvt.Ltd

Org chart

Teams

Offices

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