Products
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SYS-019: Post-Market Surveillance Procedure
CourseSYS-019 is our post-market surveillance procedure that meets the requirements for ISO 13485, the EU MDR, and SOR 98/282.
$299
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WI-008: Security Incident Response Planning
CourseThis work instruction provides detailed instructions for a security incident response to a cybersecurity incident.
$299
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SYS-007: Customer-Related Processes Procedure
CourseThe Customer-Related Processes Procedure defines the process for ensuring that customers’ requirements are met and transferred into your company operations.
$299
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SYS-006: Change Control Procedure
CourseThis procedure explains the design change control process, including the decision regarding whether a new 510(k) submission is required for modifications to 510(k) cleared device.
$299
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SYS-005: Facility, Plant, and Equipment Maintenance Procedure
CourseEquipment maintenance is commonly forgotten during audits. Do you have a Facility, Plant and Equipment Maintenance Procedure (SYS-005)?
$299
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FDA Inspection Readiness Bundle
Bundle$350