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Writing Software Requirements For IEC 62304 Compliance 9 дней назад


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Writing Software Requirements For IEC 62304 Compliance

00:00 Choosing an example: MindDoc 01:45 Documenting software requirements with a template (terrible) 05:24 A better way (Formwork eQMS) 09:39 Adding another system and software requirement 11:35 Understanding relations and creating a user need 14:25 Versioning 15:39 Creating another software requirement 16:50 Creating a Stakeholder 17:35 The requirements overview 18:36 The magical audit export 20:25 Don't over-engineer From the perspective of regulators, software is developed not by writing code, but by sitting in a dark room, smoking cigars and writing software requirements. This is not necessarily close to reality in 2025, but we will still go ahead and write software requirements, because that's what the IEC 62304 wants us to do. The software I'm using in the video is Formwork, our eQMS software. Check it out here: https://openregulatory.com/formwork

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