Quality management of the Shekan® app
This quality management policy is meant to give you an overview of the practices we have in place for the development, testing, and safety of the Shekan® app produced by us, Kanvie GbR. This policy ensures the application is reliable, convenient, and efficient while providing a safe solution to our users.
1. Development and Testing
We follow a rigorous and iterative development process with the latest design methodologies and technologies. Our developers ensure that the app’s features are free from crucial errors that impact user safety, are efficient, and user-friendly.
We also ensure that our algorithms are continually tested, using anonymous submissions from randomly selected users, to improve the accuracy of the Shekan® app. For this process, an event within the Shekan® app might randomly trigger and ask users whether they want to submit their cycle anonymously, with an additional option to submit further personal information. The user always has the ability to decline participation in this quality management process, without facing any penalties.
2. User Safety and Privacy
The safety and privacy of our users are our top priority. The manufacturer ensures that quality management submissions from users remain confidential and anonymous, as required. This includes personal details such as the user’s age, or their cycle history. Our app undergoes safety testing at every stage of the development process, ensuring that there are no severe security loopholes or vulnerabilities.
Compliance with Legal Standards:
The Shekan® app complies with all relevant legal and ethical standards. This ensures that our users can trust our app's reliability, safety, and confidentiality. We also follow strict legal protocols to ensure that the app is fully compliant with German legislation.
Continuous Review and Improvement:
We continuously review and evaluate the app's performance to ensure that it meets the needs of our users. This includes feedback from our users, identifying potential areas of improvement, and incorporating suggestions from our internal safety and testing mechanism. These reviews enable us to determine areas where we can improve the app and rectify any errors as soon as possible.
3. Conclusion
At Kanvie, we take quality management seriously. Our aim is to provide reliable, safe, and efficient cycle observation for women. We'll always ensure that our app complies with all the legal standards, ethical practices, and is up-to-date with the latest technologies to create a better user experience.
4. Information about the manufacturer, CE conformity
Shekan® is produced by:
Kanvie GbR
Speditionsstrasse 15A
40221 Duesseldorf
Germany
Shekan® is a class I medical device according to Council Directive 93/42/EEC of 14 June 1993 concerning medical devices.
Basic UDI-DI of the Shekan® app: 426244707shekanET