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Front-end development for medical devices

At Custom Medical, we develop high-quality and regulatory-compliant front-ends for your medical device that are not only usable without unacceptable risks but also designed to be visually appealing and modern, as well as functional and intuitive. Our expertise ensures that user interfaces meet the highest standards while providing an excellent user experience.

Our team at Custom Medical consists of experienced developers and designers with extensive knowledge of medical technology. We work closely with you to ensure that your product meets your specific needs and requirements.

Our expertise in front-end development

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Experience in complex applications

Our expertise in developing critical and complex applications ensures robust and reliable front-end solutions.

 

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Integrated UX expertise

As a usability and UX agency, we seamlessly integrate proven usability principles into front-end development to maximise user experience and satisfaction.

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Technology flexibility and consulting

This enables us to always use the optimum tools and frameworks for your individual requirements, allowing us to deliver customised and future-proof front-end solutions.

What we can do for you

Realisation of UI components

We develop customized UI components according to our customer’s design specifications and ensure consistency through strict adherence to style guides.

Implementation of operating procedures

We implement our customers’ operating procedures consistently and accurately in the front end to ensure intuitive and efficient use of medical devices.

Verify and validate

We test our front-end applications to ensure they are free from unacceptable risk and effective, and document the results for approval.

Documentation for approval

We produce documentation with detailed descriptions of design, development and test results to meet regulatory requirements and ensure smooth approval.

Do you have a specific project you would like us to help you with?

You can get to know us in a initial consultation with our experts.

How we take care of the front-end development of your medical device

01

Inventory

Our structured assessment lays the foundation for a successful front-end development project. By gathering information about the current status, we build up a deep understanding of your product and get to know your expectations and preferred development processes. In this way, we create the basis for a customised, secure and compliant front-end solution.

Kick-off for a Summative Evaluation / Human Factors Validation
Recruitment of participants for a summative evaluation / Human Factors Validation.

02

Kick-off

The kick-off meeting is the starting point for our joint medical device front-end development project. By defining clear goals and expectations, clarifying the framework and setting the project parameters, we create a solid foundation for successful collaboration. The established project plan and coordinated resources ensure a smooth process and efficient execution of all project phases.

03

User interface technology selection

Our support in selecting user interface technology for medical devices is comprehensive and customised. We analyse your specific needs and objectives, take into account your technical and organisational requirements and ensure compliance with all relevant regulatory requirements. In this way, we find the optimal technology foundation that delivers a superior user experience, integrates seamlessly, and meets the highest safety and quality standards.

Development of user interface components
Recruitment of participants for a summative evaluation / Human Factors Validation.

04

Development of user interface components

When developing user interface components for medical devices, we place particular emphasis on individuality, consistency and documentation. We develop customised components that exactly match your design concept and ensure a consistent look and feel through strict adherence to the style guide or design system. We also produce detailed documentation to facilitate the development process and ensure smooth integration of the components.

05

Design operating processes and workflows

We place great emphasis on precision and collaboration when implementing medical device user interface operations. We implement the required sequences using the UI components developed in step 4 and work closely with you to ensure that the sequences are user-friendly, efficient and safe. Through this structured and collaborative approach, we create a solid foundation for a successful and intuitive user interface.

Design operating processes and workflows
Recruitment of participants for a summative evaluation / Human Factors Validation.

06

Design customisation

When adapting the design of your product, we rely on regular reviews and the continuous integration of user feedback. Through iterative review and optimisation, we ensure that the design is always up to date and offers maximum usability. In the following two steps, we describethise in detail.

07

Quality assurance and testing

Our quality assurance and testing procedures ensure that the medical device user interface meets the highest quality standards and all regulatory requirements. Through comprehensive functional and user testing (see next step), we identify strengths and weaknesses in the design and correct any problems or defects. This ensures that the user interface is not only functional and reliable, but also provides an excellent user experience.

Quality assurance and testing
Iterative improvement in loops

08

Iterative improvement in loops

Our iterative improvement processes enable us to continually optimise the user interface and adapt it to your requirements. Through regular feedback rounds and updates, we respond to the needs and requirements of our customers. Making the necessary changes and retesting ensures that the improvements made achieve the desired results and provide an excellent user experience.

09

Handover of results

We hand over the results carefully and professionally to ensure that you receive all the required materials in the correct form. We hand over the source code and all relevant development documentation to you. The source code is managed throughout the development phase in a version management system, which is either provided by you or made available by us. This practice guarantees complete traceability of all changes even after handover, facilitates collaboration and ensures the quality and integrity of the project.

Handover of results

Frequently Asked Questions about front-end development for medical devices

What regulatory requirements must be considered when designing user interfaces for medical devices?

The development of user interfaces for medical devices is subject to strict regulatory requirements to ensure the safety and effectiveness of the products. Key standards and regulations include:

  • ISO 62304 (Software Lifecycle Processes): This standard specifies requirements for the life cycle of medical device software, including planning, development, verification, and validation. It requires detailed documentation and risk management processes to ensure the software is safe and reliable.
  • IEC 62366 (Usability Engineering): This standard focuses on the usability of medical devices and requires a user-centered design process. The aim is to minimize the risk of user error. The usability engineering process includes analysis of user requirements, design, and development, verification of usability, and validation in real use.
How do you ensure security and privacy in the front-end development of medical devices?

Questions about secure coding practices, authentication, encryption and compliance with data protection laws such as GDPR or HIPAA..

Which test methods and tools are recommended for validating and verifying medical device front-end applications?

Use automated testing tools, unit testing, integration testing and usability testing to ensure reliability and functionality.

How do you ensure the performance and reliability of front-end applications, especially under clinical conditions?

Optimization and testing during development. Optimising loading times, responsiveness of the user interface, and ensuring that the application is stable and reliable.

We want to get to know you and your product!

Planing of a summative evaluation or human factors validation