Software Development Compliant With IEC 62304

Standard-Compliant Software Development for Medical Devices in Conformity with IEC 62304

Medical devices and in vitro diagnostics (IVD) and their software must be developed in accordance with the European standard IEC 62304. This leads to additional requirements for the application lifecycle management (ALM), particularly with regard to risk management, testing, and documentation. However, standards and guidelines must also be met in many other industries.

We can efficiently advance your project even in a highly regulated environment!

Our Development Plan for IEC 62304

As an experienced partner for software development in accordance with IEC 62304, we have created a development plan that ensures standard-compliant development with minimal additional effort. Our employees have the expertise and tools to implement the development plan efficiently.

Process Standards in Other Industries

Standards and guidelines must be followed in many other Industries. Examples from the automotive industry include ISO 26262 and ASPICE. Our expertise in dealing with process standards can also help you implement your project efficiently.

Application Lifecycle Management (ALM)

We use the collaborative ALM software Codebeamer to implement the development plan. This allows the customer to be fully involved in the development process. Which requirement belongs to which obligation and how it was tested, is easily and completely traceable. This greatly reduces the effort required for audits.

Technology Stack

Our future-proof technology stack minimizes integration problems and follow-up costs.

Transparent Process, Strong Results.

Every project is different and comes to us at a different stage. With our understanding of the application, we can get involved even in the early stages of the project and work out the requirements together with the customer.

01

Requirement Engineering

As part of requirements engineering, we work with you to identify all relevant requirements. This process ensures that both functional and non-functional aspects are taken into account comprehensively.

02

Conception

Based on your requirements, we create a tailor-made concept for your project. We attach great importance to a clear structure and user-friendly design.

03

Architecture

A well-thought-out technical architecture forms the foundation of our solutions and ensures optimal performance. We select the appropriate technologies and development methods to best meet your current and future needs.

04

Development

During the development phase, we turn the concept we've created into a robust and scalable application. We use modern programming languages and agile methods to quickly and flexibly respond to changes.

05

Testing

To ensure a high level of quality, the application undergoes extensive testing at various stages. Continuous testing allows potential errors to be identified and corrected at an early stage.

06