progile was founded with one of its pillars being agile development. We have implemented agile processes about 10 years ago and are used to do agile development in V-Model driven documentation scenarios.
Agile coding and developing in a regulated environment do not contradict each other.
We either develop according to our ISO 13485 conform QMS or work under the umbrella of your QMS. Whatever fits you best. All software development will be done according to IEC 62304.
For fixed price projects, we generally follow our QMS and provide you a finished solution, ready for verification.
Everybody claims to follow standard conform development processes. Some are ISO 13485 certified. But how many can claim that their software passed an actual FDA Audit without any finding? Ours did!
We develop with you. But we are also there for your technical file submission or your audit.
Our approach: renewable projects
What are renewable projects. Think about why you want to work with somebody external. Either because you don’t have the required skill set in house or you don’t have the resources. In both cases, that is only a temporary situation. We build our customized development solution around this mindset.
- You don’t have the resources. Your developers might be blocked in daily business. Therefore, you reach out to us and seek a fixed price solution for your next full-scale analyzer. While the idea is, that we help you in getting the full software package up and running, you don’t want to be dependent on us for the rest of the product lifecycle. This is when the renewable approach becomes interesting: We set the projects up in a way that we can renew the teams that are developing them.
In the case that you don’t have the resources, we build and deliver the first version of your new software package for you. You might even want us to release an upgraded, more feature rich second version. But there comes the time that you want to host the project in your environment. Your teams should be able to extend the software as part of their daily business. That is exactly our use case.
- Your team does not have the skills, yet. As for the resources, we develop the first version. And together with your team, we renew the project afterwards with your team being in the driving seat.
How can we easily renew a team of a project?
The answer in one sentence: We treat your project as our product.
- Environments are virtualized and can be handed over at any point in time (not just code, the full environment)
- Documentation allows other teams to pick up easily
- Best-practice based implementations allow easy unforeseen changes
- High automated test coverage allows impact free changes (unit-test & PAVE based)
- You don’t hire individuals, you hire a team
While being able to host your project for the full lifecycle we provide the possibility to hand over for every release. We think in product cycles.