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Software Development Plan Template (IEC 62304, Medical Device)

99,00 €

This downloadable Software development plan template will provide you with a framework to complete your software development plan, or it can be used as a benchmark for your existing plan.

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Note: Software for medical devices templates are included in the SaMD and software blended courses.

Description

Why it is useful

A software development plan is required to ensure that the software development process is appropriately controlled and that it results in safe software.

How to use it

1. If you are developing a brand-new product, establish as much as possible of this plan in the planning phase of your project.
2. If you are making a revision of an old product, or adding a product to a range that this plan applies to, the plan might only have to be updated slightly.
3. Note that the plan shall be maintained, that is, it should reflect what you are doing and the other way around.
In this template, instructions and/or explanations are included using blue italic texts such as these. Instructions and explanations should be removed before review of the document.
All texts that are not blue are example texts that can and should be edited by you.
Texts that most certainly should be replaced or updated are identified by the { and } characters. They should be removed and the example text customised to work with the current project.

 

Support

If you have questions about the template’s content, you may ask questions in the support forum. The support forum is accessible on this link when logged into your Medical Device HQ account.

 

Need medical software development training and a course certificate?

If you should want to know more about medical device software development and IEC 62304, the topic is covered in our public training courses: Introduction to Software for Medical Devices and IEC 62304, Introduction to SaMD, IEC 62304 and IEC 82304-1, and Software for Medical Devices and IEC 62304 blended course. Our blended courses combine a self-paced online course first, followed by a live virtual classroom session facilitated by an industry expert.

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Would you like to learn more about risk management or design control?

Take a look at our online Risk Management course on ISO 14971:2019 and online Design Control for Medical Devices course. These courses are taken by both competent authorities, notified bodies and medical device manufacturers and distributors.

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