ISO 14155 Update: Key risk management changes for medical device clinical investigations in 2019

Futuristic HexagonsThe third edition of the ISO 14155 standard for medical device clinical investigations is expected to be published in 2019. It could be published as early as this spring and probably arrive no later than mid-year.

According to the International Organization for Standards (ISO), the updated edition will focus on a more stringent risk management approach across all stages of clinical investigations from pivotal to Post-Market Clinical Follow-up (PMCF). Continue reading