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

OUR CAPABILITIES

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