Embedded Software in Medical Device: Common Regulatory and Quality pitfalls

Software nowadays is a key component in healthcare industry. Medical device software, embedded in medical devices, can be found in several applications (network servers, smartphones, computerized information-handling system, imaging devices, …) and are intended for multiple purposes: Diagnostic, Therapy or Monitoring such as Infusion pump rate setting SW, Image processing SW, Radiation therapy planning SW, etc.

With increased use, the impact of software on the safety and performance of medical devices has also significantly increased over the years.

As part of a Medical Device, an embedded software is subject to the Medical Device Directives essential requirements. Besides the software development process, involving complex architecture, manufacturers have the obligations to ensure that the software that runs through their device is safe and effective for the patient and operator. For Europe, there is a set of regulatory and quality insurance obligations and recommendations defined in Directives, Standards and Guidance Documents.

During the webinar, we will go over the following points:

• Important definitions and Descriptions
• What is an embedded software medical device in Europe?
• How to classify an embedded software?
• Use of harmonized standard EN 62304
• Which conformity assessment route for the CE marking of my software?
• Regulation and regulators approach.