Learning Marketplace

Medical Device Software - Do you understand how software is regulated?

Helping you to understand Software as a Medical Device.

The effect of software on the safety and performance of medical devices has continued to grow in significance over recent years. This is particularly relevant when the device itself is a software only product. The assessment of software has raised more questions than answers but now there are clearer definitions and regulatory requirements that must be followed for any software classified as a medical device.

This webinar will help you too:

  • Identify the relevant directives, standards, and guidance documents recommended to develop, maintain, and validate medical software according to the state of the art.
  • Determine if software is covered by an EU medical directive for CE Marking, and if so how you classify the software.
  • Overview of basic concepts from the key software standard EN 62304 and guidance document MEDDEV 2.1/6.

No matter what stage of development you are in, this webinar will help you to plan and launch your product efficiently according to the necessary requirements.

Presenter

Greg Martinhas been a product expert and technical reviewer for BSI, on the Active Implantable Medical Devices team since 2008. He has 13 years of industry experience in the AIMD field doing research, development, and project management for pacemakers and implantable neuro-stimulators. He has extensive experience in the design of software and electronics for implants and their accessories.