Refine by
Who Standard Training Courses
2 training items found
by:ComplianceOnline based inSan Jose, CALIFORNIA (USA)
Many regulated companies have not brought their old products up to current FDA standards and are not in total compliance. This webinar defines the criteria to be used for medical products design history file remediation. For example companies should be compliant to 14971:2007. Design History Files need to be updated to meet current standards. The FDA expects risk management to be integrated into ...
by:ComplianceOnline based inSan Jose, CALIFORNIA (USA)
This medical device software development, verification and validation training package of four courses covers wellIEC 62304 requirements and explains risk based approach for validation using validation protocols and GAMP®. Medical device software can make or break a device. Badly developed, non-compliant software can compromise a device's safety and reliability. These four webinar recording ...