MEDICAL DEVICE

• Clinical trials
• Clinical evaluation
• Medical device technical documentation

ADAX can support you to compile a regulatory compliant Medical Device Technical Documentation and ensure your company achieves CE Marking certification.

We can:

• Compile your EU Technical Documentation.
• Help you determine exactly which documents need to be assembled.
• Review all existing documentation in support of meeting the applicable Essential Requirements of the Regulation(s).
• Determine applicable standards for your device.
• Review your clinical data, compile a Clinical Evaluation Report (CER).
• Review your proposed labeling and Instructions for Use.
• Prepare technical documentation for Post-Market Surveillance (PMS).
• Review and consult about your quality system.