Design Control: What should be ready before device release?

Name: Design Control: What should be ready before device release?
Uploaded: 2026-10-13T17:06:49Z
Duration: PT42.566S
Channel: Aaron Lyon
Description: Watch Aaron Lyon explain medical device release evidence, with original procedure examples, a transcript and the full Design Control guide.

Video transcript

What should be ready before releasing a medical device? Start with the exact product configuration and intended market. Then connect your design reviews, verification and validation results, risk decisions, transfer records, and required release approvals. A checklist helps reviewers find the evidence. A checkbox does not replace that evidence. Before approval, make sure each record supports the configurations you intend to release. Read AP Lyon’s Design Control Guide to see selected procedure and approval form examples.

Read the full Design Control guide

Presented and narrated by Aaron Lyon, founder of AP Lyon. Published October 13, 2026.

Original procedure and approval-form examples: SOP 7-001 Rev 3, Attachments 9 and 11, effective September 19, 2026.

Related document: Design Control Procedure. Review the included documents and examples to decide whether this procedure fits your work.

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