Person Responsible for Regulatory Compliance

BioTop Medical Dr. Teresa Lopes

Leiden, Netherlands

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.