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About (Pub) AdvaMed - Software in Medical Devices - Module 1 Regulations, Guidance, Standards, and Terminology, Planning
This document provides an overview of regulations, guidance, standards, and terminology pertaining to software in medical devices. It discusses FDA regulations for medical device software under 21 CFR 820.30, which governs design controls, and for non-medical device software under 21 CFR 820.70, which governs production and process controls. Key FDA guidance documents are also summarized, including the General Principles of Software Validation. Relevant ISO and IEC standards for medical device software are briefly outlined.
Detailed Information
| Author: | ['Aufar Rahadiandy'] |
|---|---|
| Publication Year: | 2023 |
| Pages: | 54 |
| Language: | English |
| Format: | |
| Price: | FREE |
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