We offer various services for medical device organizations to make the products and services better and complaint to requirements.
Quality Management System –
– ISO13485:2016 consultance and system gap assessment
– Training and consultancy
– EU MDR gap assessment
– FDA QSR Consultancy
– Developing QMS structure and internal audits
Product Development –
– Design Quality Engineering outsourcing
– ISO 14971 risk management training and consultancy
– Consultancy on usability, Verification & Validation
– Supplier Quality Management
– Integration and Remediation
Regulatory Support –
– Clinical Data Evaluation
– International submission including 510K and CE submissions
– CE Marking Strategy
– Regulatory strategy for different markets
Post Market –
Complaint Handling and analysis
Product Investigations and trending
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OUR CAPABILITIES
Concept Generation
"Imagination is everything. It is the preview of life’s coming attractions.” -Albert Einstein All great achievements begin with an idea. But an idea not properly developed will [...]
3D Modeling
"Words are only painted fire; a look is the fire itself". -Mark Twain Why do you need a 3D model? Why conventional 2D drawings just isn’t enough? While 2D drawings tell the [...]
Product Design
"Our environment, the world in which we live and work, is a mirror of our attitudes and expectations". -Earl Nightingale Excellent product design requires both the practical knowledge of [...]
QARA Services
We offer various services for medical device organizations to make the products and services better and complaint to requirements. Quality Management System - - ISO13485:2016 consultance and system gap assessment - [...]
Prototyping & Testing
It’s one of the critical steps among the product development in which people will be disappointed about the results Teams will be counted on their debuts Over spend of money than [...]
Hydraulic Design
Do you find Advantages changing to Hydraulics from your existing system? Do you had a requirements for setting up a new hydraulic system ? Do you have any problems with the existing [...]
