Risk Management and Instructions for Use

The instructions for use must comply with various normative requirements in addition to the IVDR, including ISO/EN ISO 14971. Furthermore, risk analysis and instructions for use play a crucial role in ensuring the safety and effectiveness of your product.

A thorough risk analysis is the basis of effective risk management. It identifies and assesses potential risks and defines measures to maintain an acceptable benefit-risk ratio. This analysis is continuously updated throughout the product lifecycle, integrating findings from performance evaluation and post-market surveillance.

The instructions for use are designed to provide users with clear and comprehensive information, enabling the safe and effective use of the product as intended.

Benefit from our broad expertise. We perform the formal review on your behalf or help you develop new documents:

• Formal assessment of your current instructions for use in accordance with IVDR
• Formal evaluation of your existing risk analysis (with a focus on methodology) against EN ISO 14971 or ISO/TR 24971
• Review of your risk analysis and instructions for use for consistency and plausibility from a clinical perspective