Company profile
Neujin Solutions Pvt.Ltd
- Industry
- Business Consulting and Services
- Employees
- 21
- Headquarters
- Vadodara, Gujarat
- LinkedIn followers
- 6,337
- Office locations
- 1
Neujin Solutions Pvt.Ltd company summary
Neujin Solutions Pvt.Ltd is a company in the Business Consulting and Services industry, headquartered in Vadodara, Gujarat. On LinkedIn the company has around 21 employees and 6,337 followers.
What technology does Neujin Solutions Pvt.Ltd use?
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About Neujin Solutions Pvt.Ltd
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
Where is Neujin Solutions Pvt.Ltd located?
Neujin Solutions Pvt.Ltd lists 1 location.
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Frequently asked questions about Neujin Solutions Pvt.Ltd
What does Neujin Solutions Pvt.Ltd do?
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
How many employees does Neujin Solutions Pvt.Ltd have?
Neujin Solutions Pvt.Ltd has around 21 employees on LinkedIn.
Where is Neujin Solutions Pvt.Ltd headquartered?
Neujin Solutions Pvt.Ltd is headquartered in Vadodara, Gujarat.
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