What we offer

We provide hands-on assistance in both, pre- and post-market activities. This means in summary (but not limited to):

• Device classification
• Interpretation and identification of the product-applicable regulatory and standard requirements
• Development, implementation and maintenance of the company quality management system

to:

• Writing / organizing the Device History File
• Writing / organizing the Technical Documentation File
• Performing and reporting/documenting the post-market surveillance activities.

Our level of involvement is determined by your needs.  We can:

• Provide advice, coaching or project management;
• Review quality and regulatory documents or write the documents;
• Perform supplier and internal audits;
• Take up functions as dedicated as a QA/RA Manager or Quality Officer or be the PRRC for your company.