Products
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SYS-010: Risk Management Procedure
CourseThis procedure is compliant with EN ISO 14971:2019. Includes templates for documentation of design, risk management, and process risk management.
$299
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SYS-004: Training Procedure
CourseThis training procedure meets the requirements for ISO 13485:2016, Clause 6.2. Included with the procedure are templates for a training record, training matrix, new employee training checklist, and training webinar.
$299
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7 Steps to Responding to FDA 483 Inspection Observations
Course$129
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Human Factors Training Series
CourseMDA's human factors training series includes all of our training webinars on human factors and usability engineering. This includes all of the templates needed to create a usability engineering file (UEF) as required by IEC 62366 and the FDA.
$950
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Internal Auditor Training Course
CourseIncludes 20 pre-recorded webinars, PDF documents as additional resources, Google Doc Templates, a pop quiz for each lesson, an 80-question final exam, and a training certificate.
$2,100
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Lead Auditor w/ SaMD Training Course
CourseIncludes 32 pre-recorded webinars, PDF documents as additional resources, Google Doc Templates, a pop quiz for each lesson, a 100-question final exam, and a training certificate.
$2,600