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SYS-002: Control of Records Procedure

Course

The Control of Records Procedure Bundle includes the Control of Records Procedure, form for documenting destruction of records, and webinar (plus exam & certificate) explaining how to review, edit, and implement your procedure for control of records.

SYS-003: Management Review

Course

This webinar shows you how to document management review requirements in meeting minutes and delegate meeting preparation effectively. Your management will be more engaging and improve in both quality and results.

SYS-008: Design Control Procedure

Course

This procedure package includes the training webinar and the following documents: 1) SYS-008, 2) FRM-018, 3) FRM-019, 4) TMP-021, 5) FRM-011, 6) TMP-022, 7) TMP-023, 8) TMP-024, 9) TMP-025, 10) TMP-026, and 11) TMP-027.

SYS-024: CAPA Procedure

Course

SYS-036: Vigilance Reporting

Course

This procedure applies to medical devices distributed in the European Union and is the primary document meeting applicable regulatory requirements for vigilance reporting for CE-marked products as defined in your company's Quality System Manual.

SYS-048: Usability Procedure

Course

This procedure meets the requirements of IEC/ISO 62366-1 (2015) and the FDA guidance on Human Factors for Medical Devices. The bundle includes a template for a summative human factors study protocol, and a training webinar.