Software development related to medical devices need to have certain structure and elements to satisfy regulative requirements. Labquality expert's has the knowhow for what to do and how.
Medical software development
When developing a software, which is a medical device itself or it is used as part of other medical device, the development must be done according to IEC 62304 process standard. It defines the elements that need to be part of the quality management system over the lifetime of the software.
Medical software is regulated in a same way as any other medical device all over the world. And within EU, depending on what the software is used for, it can be regulated with MDR 2017/745 or IVDR 2017/746.
Artificial Intelligence (AI)
Currently artificial intelligence does not have any special requirements within EU, and medical software regardless of is it considered as AI, is controlled with MDR and IVDR and applicable standards and guidances. EU act for artificial intelligence is coming within few years. US FDA has a few guidance documents regarding AI. The regulation around this topic is evolving fast. Labquality experts monitor the situation constantly and have an excellent knowhow on where we are and where we are going.
Cybersecurity is recognised within MDR and IVDR and there are one guidance document within EU available, MDCG 2019-16. This means that to show compliancy to regulatory requirements, cybersecurity activities has to be performed including evaluation of security risks in the risk analysis. Several standards for medical cybersecurity exists and some of them are in the harmonisation plan for MDR and IVDR. For US FDA, there is a long history around cybersecurity with medical devices and there are several guidance documents available.
How can we help?For software development Labquality can support in
- Develop software lifecycle management processes
- Support in defining needed documentation of medical software
- Software requirements
- Software risk analysis
- Cybersecurity implementation to development
- Software validations
- Cybersecurity risk analysis
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