Push-Med’s team has extensive knowledge of Quality System requirements and compliance related to the Quality System Regulation (QSR), ISO 13485:2003 and other quality standards and regulations.

DEVELOPING & IMPLEMENTING QUALITY SYSTEMS:
We assist our clients with the review of their current quality systems in relation to applicable quality standards.

We design, develop and assist in the implementation of integrated quality systems.

QUALITY AUDITING:

We perform quality audits directed at the entire quality system process or focused at specific areas, such as design controls, traceability, complaint system, process validation, etc.

NON-COMPLIANCE ISSUES:
We formulate practical solutions for responding to deficiency findings, FDA 483s, FDA warning letters, Notified Body non-compliance reports, etc. We also identify and provide assistance to implement all the specific steps needed to correct violations, particularly resolution of underlying quality system problems.

Additional information on services we provide can be found in the following links:

QS COMPLIANCE (USA)

QS COMPLIANCE & STANDARDS (EU)