Day

May 14, 2015
Link updated December 2018. In November 2014, Health Canada began requiring electronic submissions of license applications for Class III and Class IV medical Devices entitled: “Guidance for Industry: Formatting of Class III and Class IV Licence Applications (Electronic and Paper Formats)” File # 14-112992-741. Certain types of CDs and DVDs are specified along with information...
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Software Verification

Do you have gaps with IEC 62304 compliance or with FDA expectations for software verification?  We can help you quickly remediate gaps with unit verification including unit testing, code review, and static analysis, as well as integration and system verification testing.  Call us at 781-721-2921 or email office@softwarecpr.com to start a conversation.  We can provide estimates of cost and support your development tools.

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