About Meditix
Meditix solutions private limited established in June 2018 for the purpose of aiding medical device manufacturers in their regulatory processes and product certifications.
We offer end-to-end guidance to help your product to market.
Our expertise has hands-on industrial experience in medical device industry.
We are ISO 13485:2016 certified service provider with a scope for provision of Professional services in global regulatory to medical device manufacturers.
We solve your regulatory needs, in the way that suits you best.
Our clients rely on us completely for our works and our services, which make us long term association with them.
Today, we are providing our consulting services to several clients across the globe and cater to their needs.
Logo:
Our company logo “The modern astronomical symbol for earth with a cross (representing the equator and one meridian)” implies that we provide our compliance services worldwide and adopting and cover global current rules and regulation for medical devices.
Our Services:
Regulatory Compliance
Europe
- Complete Technical Documentation, GSPR, PSUR, Post Market Surveillance as per EU MDR 2017/745
USA
- Technical Dossier for 510k & PMA
Australia
- Common Technical Dossier as per TGA Regulation 2002
Health Canada
- Technical Dossier as per SOR/98-282
Other Country Regulations as per country specific requirements
Risk Management
- Plan & Report as per ISO 14971
Risk Management
- Plan & Report as per ISO 14971
Usability
- Formative, Summative, Unknown provenance as per IEC 62366-1
Compliance Testing Support
- IEC 60601-1 & 2 and other applicable standards
Software Development Life Cycle(SDLC)
Design History File
Preclinical Evaluation & Testing Support
- ISO 10993-1& Other applicable standards
Quality Management System
- Implementation as per ISO 13485, MDSAP, 21CFR820
Trainings
Our Mission:
Our mission is to provide Loyal service to MedicalManufacturers and Healthcare industries and to help everyone receive Quality and Safe medical devices.
Achievement:
Significant Progress in Performance – Excellence Award from CII India in Nov 2020
Working Place:
A passionate work environment and our Meditixteam members often work together, individuals treat each other with respect and company also encourages meaningful interactions between colleagues.
