Leading healthcare authorities have established regulations and guidelines for electronic instructions for medical devices. In addition there are international standards for quality management of electronic instructions. The dokspot service is designed to provide the functionalities required by these regulations. dokspot verifies and validates the eIFU software and supports you in the compliant implementation of electronic instructions according to regulations and standards.
The dokspot service is deployed on high availability infrastructure, ensuring reliable uptime to our customers. All dokspot services have failover and redundancy built-in. The dokspot network is built to defend against external attacks. Additionally, we stress test our infrastructure to ensure we can scale our performance securely and rapidly. The dokspot service is fully independent from your company website. This gives you the freedom to maintain your marketing website without compromising regulatory requirements.
dokspot is designed to keep your data safe. We collaborated with the Institute of Applied Information Technology of the Zürich University of Applied Sciences (ZHAW) to design and build a service that securely stores and provides your instructions. Every instruction you upload to dokspot is electronically signed. Checking this signature when your customers downloads the instruction allows us to provide a tamper-proof solution. We also executed penetration tests to proof the robustness of the platform against external attacks.
All dokspot activity within your organisation is tracked and logged and provided via a dashboard. If needed a complete eIFU audit trail can be documented. On a platform level we control continuously that the service is running properly. As part of our incident management service we log requests and review them regularly for improvement opportunities.
We backup all your data on the dokspot Service every 24 hours. We also make daily, weekly and monthly snapshots. If ever required, we can rollback your data and contents on dokspot with minimum data loss to a previous state.