Webinar – How to develop medical software that conforms to IEC 62304
Register and join us online on February 8
A wide variety of medical devices incorporate embedded software. Some of these such as: X-ray scanners, heart rate, blood pressure and breathing monitors, are used for analyzing patients. Others such as defibrillator and medication pumps, are used to treat patients. In both cases, people’s health and safety depend on the medical software deployed being reliable, safe and bug-free. The other aspect is medical app which can facilitate physician’s decision, diagnose symptoms, or give suggestion to treatment.
·The International Electrotechnical Commission created the IEC 62304 standard which outlines the requirements for medical software life cycle process.
This standard can be used to both embedded and standalone software. The compliance to this standard implies that the essential requirements regarding software life cycle in Annex I of the EU directives MDD 93/42/EEC are fulfilled. Developing medical software according to this standard helps manufacturers to achieve one of the important steps in order to place the product in the EU markets.
·What are the key points of this standard? What are the tips for developing medical software regarding to this standard?
We answer these and many other questions in this eHealth HUB live webinar.
·Who is this webinar for: Startups, SMEs, Companies that develop medical software
·When: 8th February 2018 – 11:00 – 12:00 CET
- Introduction in IEC 62304
- Software Safety Class and its impact to the development activities and documentation
- Key points for the software life-cycle process
- How to deal with “legacy software”
- The approach to easier compliance
- Relation to FDA
- Level of concern vs. software safety class
- Software documentation
- Live Demo
Ittipan Kanluan, a Regulatory Affairs Expert in the field of Active Medical Devices / Medical Software at CE plus GmbH, an international service provider for medical devices and in vitro diagnostics based in Germany. At CE plus, he is responsible for Active Medical Devices and Medical Software. He supports clients in the software life-cycle process according to IEC 62304, risk management according to EN ISO 14971, usability engineering according to IEC 62366, and requirements engineering.
Ingo Nickles is Senior Field Application Engineer at Vector Software, where he is responsible for customer and project support. He has over 25 years of professional experience in software development, system design and software testing and agile development methods.
We wait for you online, 8th February 2018 – 11:00 – 12:00 CET!
If you have any questions please email: Ittipan.Kanluan@ceplus.eu
This webinar is free of charge and it is funded under the European Commission H2020 eHealth Hub project