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

– 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

January 12th, 2014|

"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

January 5th, 2014|

"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

January 5th, 2014|

"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

January 5th, 2014|

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

January 5th, 2014|

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

January 5th, 2014|

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 [...]

By |January 5th, 2014|Categories: Product Design|Comments Off on QARA Services