Medical software
Software development related to medical devices needs to have certain structures and elements to satisfy regulative requirements. Labquality's experts have the know-how for what to do and how.
Medical software development
When developing software, which is a medical device itself or is used as part of other medical devices, 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 the same way as any other medical device all over the world. And within the 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 the EU, and medical software regardless of whether it is considered as AI, is controlled with MDR and IVDR and applicable standards and guidances. EU act for artificial intelligence is coming within a 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 know-how on where we are and where we are going.
Cybersecurity
Cybersecurity is recognised within MDR and IVDR and there is one guidance document available within the EU, MDCG 2019-16. This means that to show compliance with regulatory requirements, cybersecurity activities have to be performed including evaluation of security risks in the risk analysis. Several standards for medical cybersecurity exist and some of them are in the harmonisation plan for MDR and IVDR. For US FDA, there is a long history of cybersecurity with medical devices and there are several guidance documents available.
Labquality
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
Contact us for more information
Leave a contact request
Related Services
Electrical Safety IEC 60601
IEC 60601-1 is the basic safety standard for medical electrical devices and systems.
Biological Safety ISO 10993
We provide medical device manufacturers help with setting up a biological safety evaluation process and preparing biological evaluation documentation.
IVD Performance Evaluation
Labquality helps manufacturers comply with the clinical evidence requirements of the IVD Regulation.
Risk Management ISO 14971
Labquality provides medical device manufacturers help in setting up and implementing a risk management system and preparing risk management documentation.
Qualification and classification of medical devices
Our team’s versatile experience and the available tools help in bringing clarity to the challenging cases.
Regulatory plan
Labquality can help medical device manufacturers in creating a regulatory plan.
IVDR compliance for in-house developed tests
Laboratories developing IVDs in-house must maintain Technical Documentation and Quality Management Systems to comply with the IVDR and the national law.
For Startups, Incubators and Institutions
Regulatory compliance is a struggle for Health Tech innovators and startups where ever you go.
EU MDR and IVDR
Labquality provides medical device manufacturers help with understanding the changing regulations that set the standards of quality and safety of medical devices.