CENELEC Proposal on Software and MDD

The EU standardization organizations, CEN and CENELEC, have formed a joint working group on standards for software and medical devices (SAMD). The first meeting will be December 8th. Notice is at the link provided. With the harmonization of IEC 62304 (including for IVD devices), potential modifications to the scope of 60601, and the recent Medical Device Directive changes taking effect in March 2010, the focus on software in the medical device field (including standalone software) continues to increase.

CENELEC Proposal

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

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