Compliance-by-design IoT prototyping
i46 can help start-up and innovators bring their idea to the market with our compliance-by design IoT prototyping
What is compliance-by design?
Compliance-by-design is the practice of embedding regulatory requirements into technology and processes from the very start: an IoT device's design phase. It ensures that legal, security, and privacy standards are integrated into every stage of development, making compliance an inherent part of the system.
Compliance-by-design benefits
By embedding compliance from the start, businesses avoid costly retrofits, reduce legal risks, and streamline regulatory approval. Compliance-by-design strengthens security, enhances trust, and ensures resilience against evolving regulations. With i46’s compliant device prototyping, companies can bring products to market faster.
i46, your compliance partner
i46 provides expert guidance, helping businesses navigate complex compliance landscapes with confidence. From the GDPR to the CRA and other related laws such as the AI Act and Data Act, i46's design and prototyping services ensures compliance is built-in, not bolted on—so you can focus on innovation,.
Step-by-step design and prototyping
Phase 1: Defining the Product
The first phase enables i46 to gain a broad understanding of the customer’s vision, goals, and desired functionalities. We identify key use cases, and target users to establish a clear direction for IoT product design before moving into compliance and technical considerations.
Phase 2: Legal Requirements
The second phase is about identifying and analyzing relevant regulations (CRA, GDPR, Data Act, and AI Act, Accessibility Act depending on the product) to determine their impact on design, data handling, and security. Understanding these obligations early ensures the product is built to meet compliance standards rather than adapted retroactively.
Phase 3: Aligning Legal & Technical Needs
In this phase, we translate legal requirements into concrete technical and user-driven design choices. We balance regulatory obligations with functionality, security, and user experience, ensuring compliance is well integrated into the product’s architecture without compromising performance or innovation.
Phase 4: Prototyping
In phase 4, we develop an initial working model that incorporates compliance principles with technical and user requirements defined in Phases 1 through 3. This can include both a HW prototype, a SW prototype (i.e: a remote data processing solution) or either one of them.
Phase 5: Testing & Enhancements
Once a prototype is ready, i46 conducts rigorous testing to assess security, usability, and compliance readiness. In this phase, we identify vulnerabilities, refine features, and enhance safeguards to ensure the product meets legal requirements while delivering a positive user experience.
Phase 6: Validation
The final phase, Validation, is about verifying that the final prototype aligns with all legal, technical, and customer's expectations. In this phase, i46 prepares the required legal documentation for CRA certification, and delivers a fully certified prototype to the customer.
Case Study: OpsezN
An IoT device for Language Analysis
Overview
Compliance Challenges & Solutions
Given the sensitivity of network data and personal identifiers, GDPR compliance was a key concern that guided the overall system’s architecture. To address this, i46 designed an edge-based architecture ensuring data processing occurs directly on the device. Personally identifiable information (PII) are to be discarded immediately, no persistent storage is to be used, and disk encryption safeguards any temporary data.Cybersecurity requirements under the Cyber Resilience Act were also a priority. A thorough risk assessment guided the implementation of security measures, including encrypted data storage and transmission, controlled access to the dashboard, and other safeguards to protect system integrity.
English 
Chinese