Risk Management

MedOrdyn provides structured, lifecycle-based Risk Management support aligned with ISO 14971, enabling manufacturers to systematically identify, evaluate, control, and monitor risks associated with medical devices and Software as a Medical Device (SaMD). Our approach follows the complete risk management process, including risk analysis, risk evaluation, risk control, and production and post-production monitoring activities, ensuring full alignment with global regulatory expectations.

We support the development and refinement of Risk Management Plans, establishment of risk acceptability criteria, and creation of comprehensive Risk Management Files with full traceability across hazards, hazardous situations, risk estimations, and implemented control measures. Our services include hazard identification, risk estimation based on severity and probability of harm, implementation and verification of risk control measures, and evaluation of residual risks including benefit-risk analysis where applicable.

By integrating risk management throughout the entire product lifecycle, from design and development to post-market surveillance, MedOrdyn ensures that risk controls remain effective, regulatory submissions are strengthened, and compliance is sustained in accordance with international standards.