Glossary Term
Adverse Event (AE)
Definition
An Adverse Event (AE) is any undesirable experience or unintended effect associated with the use of a medical device or therapy, whether or not it is directly caused by the product. AEs can range from minor complications to serious outcomes such as injury, hospitalization, or death, and they are a key focus of safety monitoring throughout a medical device’s lifecycle.
Relevance to the MedTech Industry
Adverse Event monitoring is essential for ensuring the safety of medical devices and protecting patients. By identifying, documenting, and analyzing AEs, manufacturers can improve product design, implement corrective actions, and comply with regulatory requirements for post-market surveillance and risk management.
Additional Information & Related Terms
Post-Market Surveillance Monitors AEs and ensures continued device safety and effectiveness.
Risk Management File (ISO 14971) Documents risks associated with AEs and mitigation strategies.
Corrective and Preventive Actions (CAPA) Addresses and prevents recurrence of issues linked to AEs.
Medical Device Reporting (MDR) Regulatory requirement for submitting AE reports to authorities.