The International Medical Device Regulators Forum (IMDRF) SaMD draft of a quality system for Software as a Medical Device is available for public comment.Read More

The ballot on the final draft of the IEC 62304 amendment, which focuses on safety classification and legacy software, closes in May. We expect publication by July, followed by a consolidated version that incorporates the amendment. Adoption by CENELEC as an EN is happening concurrently, so harmonization by the EU should happen late this year...Read More