When trying to come up with new and innovative solutions to support patients and healthcare providers in the medical device industry, medical device manufacturers often end up with solutions that include software. In fact, there are many opportunities to enhance existing products with software: For example by complementing existing products with a mobile phone app that patients can use from their homes. Programming a mobile phone app or also other software programs can be done sometimes quite easily, but what needs to be considered when actually placing such medical device software on the market?
This training will provide medical device manufacturers with helpful information on the challenges, pitfalls and of course solutions when intending to add software products to their portfolio.
- Background information on medical device software (definitions, regularory requirements, markets etc.)
- Pro`s and con`s for adding software to a medical device manufacturer’s product portfolio
- Some initial decisions to be taken and pitfalls to avoid, when actually deciding to add software to the product portfolio
- The product life cycle for products containing software
- The quality management system when managing products containing software