Our development platform H.Core is powered by behavioral intelligence and real-world evidence.
Built on our expertise in healthcare, technology and behavioural science.
H.Core integrates our QMS with a library of reusable components to build and operate clinical grade SaMDs.
A behavioral science engine, continuously informed by consented real world data.
An AI and machine learning layer trains, validates, and monitors clinical models.
H.Core is the engine behind our products and our Pharma collaborations, turning data and design into clinical grade software.
Ship SaMD faster. De-risk regulatory compliance building on a solid foundational core.
Get to patient insights faster. Our platform provides the shortest, safest route to real-world data and user interaction analysis. Benefit from built-in data protection and integrity measures to start collecting and aggregating trustworthy data for clinical evidence and market validation.
Proven EU MDR Heritage
Leverage a software framework that has already served as the foundational component for multiple EU MDR Class IIa SaMDs, meaning the platform's core architecture, risk management documentation (per ISO 14971), and established development lifecycle (per IEC 62304) are demonstrably compliant with European regulations. This technical heritage dramatically de-risks the certification process for new applications built on top of the platform.
Qualified Clinical Modules
Accelerate development by integrating pre-qualified software modules that address common SaMD functionalities. These include validated components for Authentication, Authorization, Patient Consent Tracking, Adherence/Pill Reminders, and Secure Data Management. Reusing components already developed and documented following IEC 62304 SDLC enables downstream solutions to inherit compliance evidence, drastically reducing the regulatory validation effort for new SaMD products.
Foundational Privacy-by-Design
Built-in encryption, pseudonymization, access control, and audit trails ensure full GDPR / HIPAA alignment. Sensitive patient data is protected at rest and in transit, fulfilling key requirements of global data protection laws straight out of the box. Technical controls for separating patient identity from clinical data are enforced at the architectural level, significantly simplifying regulatory sign-off on data handling procedures.
Data Aggregation for Efficacy
The architecture is designed to aggregate patient data from various sources securely and anonymously into a centralized analytics layer. This unique technical capability provides a robust, compliant data set essential to enabling data-driven analysis of user behavior in human-factors engineering and for clinical efficacy and safety evidence generation in post-market surveillance (PMS).
Pre-Validated Data Integrity
Implement 21 CFR Part 11 and GxP compliant data handling out-of-the-box. The platform enforces mandatory, immutable audit trails for all electronic records and transactions. This technical foundation guarantees data authenticity and integrity from patient data ingestion to derived analytics, significantly reducing the burden of validation and quality assurance for the end-user SaMD, ensuring regulatory compliance is a feature, not a separate project.
Deployment Flexibility
Gain maximum operational flexibility with a platform designed for true deployment agnosticism. The software can be hosted seamlessly across any major cloud provider (AWS, Azure, Google Cloud, etc.) or within an on-premise infrastructure. This architectural design avoids vendor lock-in, allows the client to satisfy local data residency requirements, and meets corporate IT security standards, optimizing both cost and compliance posture globally.
Secure-by-Maintenance
Benefit from continuous platform-level vulnerability scanning, patch management, and automated SBOM updates. The framework is developed to minimize its reliance on third-party libraries, and any component is continuously monitored and updated, exceeding basic regulatory requirements. This proactive, integrated security lifecycle ensures that the core component of your SaMD remains resilient against emerging threats, fulfilling modern, stringent cybersecurity compliance requirements with minimal effort.
Continuous Auditing
Benefit from a continuous compliance cycle where all changes and updates to the platform undergo an integrated, shared auditing process. Since the framework underpins multiple regulated SaMDs, all necessary compliance efforts (e.g., changes to cybersecurity, data protection, and component qualification) are consolidated and reviewed once, propagating compliance gains to all products.
Low Third-Party Risk Footprint
The software is engineered with a philosophy of minimizing external dependencies, resulting in the smallest possible Software Bill of Materials (SBOM). A smaller SBOM directly translates to a lower regulatory compliance burden regarding third-party software qualification, license management, and vulnerability monitoring, offering a demonstrably reduced risk profile for the final medical device.
Partner with Us to Accelerate Digital Health Innovation
Whether exploring digital endpoints in early discovery or seeking a companion therapeutic for a marketed product, Newel Health offers collaboration opportunities across the full digital medical device lifecycle.
