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
Company Details
- Employees
- 18
- Address
- Vadodara, Gujarat 390007, In
- Industry
- Business Consulting And Services
- NAICS
-
Management, Scientific, and Technical Consulting ServicesManagement Consulting ServicesOther Scientific and Technical Consulting ServicesOther Management Consulting Services
- Website
- http://www.neujinsolutions.com
- Keywords
- Vadodara.
- HQ
- Vadodara, Gujarat
Neujin Solutions Questions
Neujin Solutions's website is http://www.neujinsolutions.com
Neujin Solutions's LinkedIn profile is https://in.linkedin.com/company/neujin
Neujin Solutions has
18 employees.
View email and phone details for 18
employees at Neujin Solutions.
Neujin Solutions's industry is
Business Consulting and Services
Neujin Solutions's top competitors are
Meril,
Elexes Medical Consulting Llc,
Axio Biosolutions,
Griportho Medical Devices,
Maven Profcon Services Llp,
Advanced Medtech Solutions (Ams),
I3cglobal,
Healthium Medtech Limited,
Aegis Lifesciences Pvt Ltd,
Salvation Global.
Neujin Solutions's categories are Business Consulting and Services
