Day

August 19, 2015
19
Aug

FDA Quarterly MDR Reporting Pilot Program

August 19, 2015
http://www.gpo.gov/fdsys/pkg/FR-2015-08-18/html/2015-20309.htm
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19
Aug

Cl II BIOTRONIK Pacemaker Programmer software

August 19, 2015
Company: BIOTRONIK Inc.. Date of Enforcement Report 8/19/2015 Class lI: PRODUCT PSW 1203.U/1, PSW 1301.U, PSW 1307.U, PSW 1403.U, and PSW 1501.U Pacemaker Programmer software. Software approved for use with BIOTRONIK device programmers (trade names: Renamic and ICS 3000). Allows physicians to program devices to pace exclusively in the left ventricle. Recall Number Z-2376-2015 REASON...
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SoftwareCPR Training Courses:

IEC 62304 and other Emerging Standards Impacting Medical Device Software

Being Agile & Yet Compliant

ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

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