The use of software in medical devices or of software as a medical device offers many new possibilities for more precise diagnoses and more efficient therapies. For example, it is much easier to link data for a diagnosis or to implement new treatment and diagnostic procedures. Software that is designed for this purpose is also subject to the analogous regulatory requirements and standards that apply, for example, to ventilators or implants. However, software is particularly difficult to classify within this regulatory framework and is often a matter of interpretation. Often it comes down to the so-called intended purpose.
This certificate program introduces you to the world of regulatory terminology and explains why the intended purpose is of fundamental importance from the outset for anyone developing software in connection with the diagnosis or treatment of diseases. And why proper classification is as important as the product idea itself. In our online course to become a Medical Software Specialist, you will gain the knowledge you need to navigate this complex environment step by step. This includes sound knowledge of the relevant laws, standards and regulations, as well as how the software lifecycle is integrated into the quality management and risk management systems.
The developers of software for or as medical devices are ultimately more than just software developers. They create software products that, in addition to a clinically proven benefit for patients, must not pose an unacceptable risk. Therefore, they must fulfill all legal requirements for medical devices. Manufacturers of software for or as medical devices therefore need specialists who have sound technical knowledge as well as regulatory and clinical expertise. These specialists are very much in demand! The medical device market is one of the most innovative and fastest growing markets of the last years.
- Development of software for medical devices: September 11, 2023 | 9am – 4.30pm
- Implementation of IEC 62304 and IEC 82304-1 for medical device software manufacturers: September 25, 2023 | 9am – 4.30pm
- Risk management for medical device software – ISO 14971: October 2, 2023 | 9am – 4.30pm
- UX and Usability for Medical Software and Apps – IEC 62366-1: October 10, 2023 | 9am – 4.30pm
- Cybersecurity – IT security for medical devices: October 13, 2023 | 9am – 4.30pm
Single modules also available!
- Medical device manufacturers whose products contain software or are software products in their own right, from the areas of regulatory affairs, quality management, systems and software engineering, usability engineering, requirements engineering, project management, risk management, product management, IT, management,
- Service provider / supplier in the medical technology,
- Consultants for medical software
- Newcomer & Start-Ups
- Early bird (until August 11, 2023): Euro 2.190,- (excl. VAT)
- Standard (starting with August 12, 2023): Euro 2.390,- (excl. VAT)
LISAvienna's network partners are invited to claim a 10% discount.