Development of a Region-based eIFU (Electronic Instructions for Use) System

In this project, data synchronization and consistency stand out as crucial aspects. We have implemented strategies, technologies, and protocols to guarantee that information stays accurate and up-to-date across the Sharepoint systems and IFU Portal.

Solution Design

Region-based document versioning

• Automatic synchronization of eIFU documents between SharePoint and eIFU Portal upon internal process approvals in SharePoint.

• Future-proof design with multilingual support.

• Regional availability of eIFU documents, organized by region and offered in different languages for user accessibility.

• Well-maintained document versioning during document synchronization between systems.

• Document subscription feature to notify users of new document releases.

• Cloud deployment utilizing Azure Storage, Function App, Key Vault, CosmosDB, and Monitor.

• Cloud security features including cloud-based JWT authentication tokens, registration, and Webhook event listener. User data secured in Azure Cloud Vault in compliance with European GDPR (General Data Protection Regulation).

A Process-Oriented Approach 

Mindteck’s team covered the entire spectrum of development, ranging from design and SharePoint support to prototyping, complete integration, and testing.

Cloud and Software Expertise: Mindteck’s proficiency was demonstrated through the seamless design and development of a Web Portal serving as a repository (with search and download options) for Cascination’s Medical Equipment by registered external users.

Push-based Design: Automatic Email Notification through user-driven subscription, ensuring swift distribution of updates.

Scalable Solution: Facilitates easy management, scalability, and document distribution using Azure cloud and SharePoint.

Compliance with Medical Industry Standards: Ensuring compliance with GDPR for the storage of personal identity information (PII). Development adheres to MDR (2021/2226) for eIFUs, providing necessary compliance evidence, and follows ISO 14971 for risk assessment and ISO 13485 standards for development.

Outcome

Developing a user-friendly solution for document distribution

Mindteck’s comprehensive strategy facilitated the seamless integration of the eIFU Portal, SharePoint, and Azure services. The system was designed to promptly inform users about the latest manuals and instructions for use, with an emphasis on simplifying the interface for an enhanced user experience.