Video Guides
Short medical device documentation guides from Aaron Lyon, with procedure examples and links to the full written guides.
Watch with transcript: Design Control · Risk Management · Software Development · Clinical Evaluation
Design Control: What should be ready before device release?
Connect the exact product configuration and intended market with design reviews, verification and validation, risk decisions, transfer records and required approvals. A checklist helps locate evidence; a checked box does not replace it.
Narration recorded by Aaron Lyon. Procedure excerpts from SOP 7-001 Rev 3, effective September 19, 2026.
Risk Management: How do your plan and report connect?
Set responsibilities, methods and criteria in the risk plan. Connect hazards and hazardous situations to controls, retain implementation and effectiveness evidence, and bring results and remaining-risk conclusions together in the report. Revisit the analysis when product changes or new information affect those conclusions.
Narration recorded by Aaron Lyon. Original excerpts from FORM 0033 and SOP 7-003 Rev 2, effective September 19, 2026.
Software Development: What should your plan cover beyond coding?
Define scope, safety classification, lifecycle, deliverables and responsibilities. Plan verification and validation, configuration control, anomaly handling, security and release evidence. Include supplier interfaces, maintenance and end-of-support arrangements, and keep the plan current as the project changes.
Narration recorded by Aaron Lyon. Original planning excerpt from SOP 7-043 Rev 2, section 7.1.1, effective September 19, 2026.
Clinical Evaluation: Could another reviewer reproduce your literature search?
Document data sources and their justification, search terms, date limits, selection criteria, duplicate-data handling, and appraisal and analysis methods. Check search adequacy and record the execution and any deviations from the protocol so another reviewer can assess the methods and results.
Narration recorded by Aaron Lyon. Original literature-search excerpts from SOP 7-038 Rev 2, page 10, effective September 19, 2026.