Agile approach to software development for medical devices without compromising patient safety and regulation compliance
Medical industry comprises projects with complex software used in medical devices and systems that operate in a highly regulated environment, stipulated by regulations, laws, and standards. The requirement is to ensure the appropriate level of software quality, as it can greatly affect user and patients safety. Understandably, failure of such project can have a high cost, both socially and financially.
Can agile help?
Yes. When done right, agile approach to software development of medical devices:
- Complies with regulatory requirements,
- Helps bringing products to market faster,
- Serves patients safety.
This whitepaper will also help you better understand:
- Common misconceptions about agile approach in highly regulated environments,
- Main benefits of agile methodology compared to waterfall,
- Best approach to mapping of regulated activities into agile approach to software development for medical devices.
Read more on the topic by submiting the form on the right.