Comprehensive technical documentation service supporting medical device regulatory compliance. Includes literature search reports, clinical and performance evaluations, biological assessments, usability engineering documents, risk management files, post-market surveillance plans, and periodic safety...
Manufactured by
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.
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