Software architecture · AI · Medical devices
We bring deep software development experience to medical device software and AI: shaping architecture, supporting implementation and reviewing complex systems. We also help build the teams, QMS processes and regulatory software strategy needed to move towards submission.
Our expertise
Our architecture advice is grounded in hands-on software development. We help teams make sound technical decisions, turn designs into working software and strengthen existing systems, alongside the teams and processes needed to deliver them.
Support from architectural direction and detailed design to hands-on software and AI development. Define system boundaries, interfaces and integration choices with maintainability and testability in mind. Medtech is our specialty, including software as a medical device (SaMD) and software within a wider device.
An independent assessment of an existing architecture or proposed design. Review system structure, dependencies, interfaces, maintainability and key technical risks. Receive prioritized findings, clear trade-offs and practical recommendations. Available across industries, as a focused review or follow-up architecture support.
Help define roles, team structure and technical leadership as the organization grows. Establish effective collaboration between software, AI, product and quality teams, with clear responsibilities and ways of working.
Help define the software and AI lifecycle within your quality management system. Connect development practices, risk management, verification and documentation with the product’s regulatory software strategy and submission needs.
Recent engagement
Medical technology
Recently supported Usono with building its software and AI teams, strengthening software development processes, and preparing product development for medical device submission.
How we work
Focused reviews, technical advice or a broader development challenge. We agree on what is needed and work alongside your team to move it forward.
Start with the product, the organization and the decisions ahead. Identify what is working and where support will have the most value.
Define priorities, responsibilities and a useful scope. Turn technical and process questions into an actionable plan.
Support the review, development or implementation. Leave the team with clear decisions, practical recommendations and stronger capability.
AI can support analysis and development; professional judgment guides the conclusions. The use of AI and the handling of client materials are agreed as part of each engagement.
About Clear Sign Digital
Clear Sign Digital is owned and run by René van Erp. René brings deep, hands-on software development experience and software architecture expertise to complex product development. That practical foundation informs our architecture reviews, technical direction and implementation support.
Medtech is our specialty, with experience in software and AI team development, quality processes and regulatory software strategy. We also support companies in other industries through architecture reviews and software development advice. Engagements are scoped around your product, your team and the decisions you need to make.
Let’s talk
Tell us about your product, a development challenge or an architecture you would like reviewed. We can explore where Clear Sign Digital can help.
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