Regulatory Affairs and Quality Experts at IVD and medical device manufacturers face increasing regulatory requirements and product complexities.

This results in longer approval processes, high workloads, and decreased job satisfaction, making it hard to stay competitive. Our software solution streamlines these regulatory processes, improves transparency, and shortens time-to-market.

Necessary Steps for Improvement

To enhance efficiency and compliance, it is crucial to implement structured data collection, avoiding redundant information and ensuring a streamlined technical documentation. Additionally, conducting plausibility checks on content and maintaining clear communication with the notified body are essential steps for improvement.

My Responsibilities

• Conducting interviews with stakeholders

• Deriving user requirements

• Creating concepts and workflows

• Validating and testing concepts and workflows

• Responsible for the initial visual design of the software

• Maintaining close communication with colleagues from the IT department

• Analyzing the usage of the implemented concepts by end-users

The Users and Stakeholders

Our users are not the same as our stakeholders. The stakeholders are in-house experts who help conceptualize technical documentation as a structured data collection, meeting legal requirements across various modules like risk management, clinical evaluation, and biocompatibility. This involves integrating knowledge from different domains into a unified data model, while simultaneously ensuring it is presented in a user-friendly manner.

Meanwhile, the software must include essential features such as user management, legally compliant document approvals, collaboration tools, and project management functions.

Visual Design

Our visual design aims for a light, modern look, focusing on essential elements to convey information effectively. The overall design is clean and straightforward, ensuring excellent readability and user-friendliness.

User Flows

For each feature, we create detailed user flows to facilitate easier implementation and understanding for the IT team. This process ensures that every aspect is thoroughly considered, with user-friendliness as the top priority.

See a "simple" user flow below.

Screen Design

I developed a modular system based on the framework, emphasizing the reuse of modules and functionalities to minimize user frustration and leverage familiar patterns. It's crucial to maintain information density as low as possible while ensuring it is sufficiently high to meet user needs. Despite the product's complex nature, my work prioritizes user-friendliness, ease of use, and a consistent design throughout.

Takeaway

From this project, I have developed a passion for simplifying complex issues for users and gained valuable experience in interdisciplinary communication with development and project planning teams.

Creating a model that captures all necessary data without redundancy was a significant challenge.

The next step is to implement logic for data plausibility checks, further simplifying the user’s work. This demanding project offers an excellent opportunity to oversee and enhance a project from the start.