Basics of Medical Device Design Controls: What, Why, and How
Basics of Medical Device Design Controls: What, Why, and How Article contents: Think of Design Control as a FrameworkDesign Control-Related Processes in ISO 13485:2016 and FDA 21 CFR 820When Does Design Control Begin and End?The Overall Design Control ModelSetting the Stage with Design ReviewsMedical Device Design Control PlanningChange and Configuration ManagementMedical Device Design Inputs, Outputs, […]
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Medical Device Change Management Process Best Practices
Medical Device Change Management Process Best Practices The one thing that remains constant in the medical device world is the frequency and need for change. In fact, the emphasis on the ├óΓé¼┼ômanagement├óΓé¼┬¥ of change has increased over the past few years with changes in the regulations and standards. It is the key process that drives […]
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Medical Device Equivalence: How Close Does It Need to Be Under the EU MDR and MEDDEV 2.7/1 rev 4?
Medical Device Equivalence: How Close Does It Need to Be Under the EU MDR and MEDDEV 2.7/1 rev 4? While there are several new requirements related to clinical evaluation report content contained in MEDDEV 2.7/1 rev 4 and the MDR, one of the more perplexing issues concerns the issue of equivalency. Companies selling devices that […]
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FDA 21 CFR Part 11 Compliance: Are You Complying With These Four Critical Electronic Records Requirements?
FDA 21 CFR Part 11 Compliance: Are You Complying With These Four Critical Electronic Records Requirements? The first paragraph of├é┬á21 CFR Part 11├é┬áseems disarmingly straightforward. It says: ├óΓé¼┼ôThe regulations in this part set forth the criteria under which the agency considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, […]
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