Medical Devices

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Quality Management System Implementation

Whether you need a new or refined medical device quality management system (QMS), we know the processes needed to meet US FDA, MDSAP, ISO 13485:2016, and other global requirements. Let us help you build a local or global QMS. Need an informational security management system? No problem!

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Regulatory Strategy

We have successfully prepared global regulatory strategies and submission files for medical devices that led to timely approvals in the US (FDA), Canada, EU (CE marking), and other health authorities. We pride ourselves on being able to meet your local and global needs and offer an international registration file that includes the common registration elements. 

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Internal and External Auditing

Our auditors are skilled and certified with experience in internal, business unit, customer, regulatory agency, and supplier auditing for medical devices .