The 62304 is a standard from the ISO which deals with the lifecycle management of medical software and the software used in medical devices. It goes without saying that risk management is central to the implementation of this standard and is inbuilt into it.
In the advanced medical devices markets of the world, such the European Union and the US, or Japan and China or just any other market, the application of ISO 62304 is mandatory for medical devices. They form a core part of the regulatory requirements of most of these markets. This means that medical device organizations who do not get their ISO 62304 implementation right face the risk of regulatory action.
The medical software development file is a very crucial component of the development process and the lifecycle of medical software in accordance with ISO 62304. How to apply the ISO 62304 in the medical software development process and how to create a medical software development file are thus very important to learn for medical device companies.
Compliance4All, a leading professional training platform that offers cost-effective learning on all the areas of regulatory compliance, is organizing a webinar on June 11, at which all the aspects of applying the ISO 62304 in the medical software development process and the knowledge of the right way of creating a medical software development file that meets regulatory expectations, will be taught.
At this webinar, Prof. Dr. h.c. Frank Stein, a very senior and highly respected medical device academic and professional, will be the expert. To enroll for this ninety-minute session.
The essence of the learning this webinar will offer is that it will help participants understand what the ISO 62304 for medical software is, and how this standard works. Participants will gain valuable learning of how to apply the ISO 62304 in the medical software development process and how to create a medical software development file.
This will help them understand how to apply this standard smartly in a medical software development project during both the medical software development and in the post market process stages.
Prof. Dr. h.c. Frank Stein will cover the following areas at this webinar:
- What is the scope of the ISO 62304?
- What are the requirements of ISO 62304 in medical software development processes and the medical software life cycle?
- Which companies must apply ISO 62304?
- How to implement ISO 62304 in a smart way into a medical software development project and in a quality management system according ISO 13485?
- How to use the ISO 62304 in the Post Market Process according ISO 13485 and the EU MDR?
- What are the expectations of European Notified Bodies?
This learning is of invaluable assistance to professionals such as
- CEO’s of companies which sell to Europe medical software or medical devices with software
- Regulatory Affairs Managers of companies which sell to Europe medical software or medical devices with software
- Quality Managers of companies which sell to Europe medical software or medical devices with software
- Quality Representatives of companies which sell medical software or medical devices with software to Europe
- Other Managers who deal with regulatory or quality guidelines or medical software for medical devices with software.
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