Medical Device Software

Prototyping

• Rapid prototyping using our robust Onemo framework.
Onemo^® is a powerful framework created by Cerebellis to speed up software development for medical device prototyping. It provides a solid, scalable base for quickly building software while ensuring compliance with key regulations, including traceability and data integrity. Onemo makes it easy to develop web-based, embedded, and connected applications without starting from scratch. By simplifying the prototyping process, it helps manufacturers bring innovative and reliable software to market faster and with confidence.
• Cost-effective and time-saving: build once, refine continuously.
Our approach ensures your prototype is not just a starting point but a foundation for the final product. Using our Onemo framework, we build scalable and compliant solutions from the start, saving time and costs by refining continuously instead of redesigning. This seamless evolution minimizes delays and rework, helping medical device manufacturers innovate efficiently while staying on budget and meeting regulatory requirements.
• Compliance built-in: adheres to GxP, CE Marking, cybersecurity, GDPR, and more.
Onemo comes with built-in compliance features designed for the strict requirements of regulated industries like Life Sciences. It ensures your software aligns with GxP, CE Marking, GDPR, and cybersecurity standards from the start. With traceability, data integrity, and secure health data management at its core, Onemo simplifies the development process and helps you prototype faster. Proven in regulated environments, it reduces risks and streamlines the path to compliant software, so medical device manufacturers can focus on innovation without being overwhelmed by regulatory hurdles.
• Proven reliability in Life Sciences software for managing regulated processes and data.
Our solutions, built on the Onemo framework, are rigorously tested and proven reliable in various Life Sciences applications. Onemo allows for rapid development of compliant software, ensuring data integrity and traceability while adhering to industry standards. This robust framework has successfully supported critical activities in clinical research and laboratory data management. By leveraging Onemo, we provide scalable and secure solutions that effectively meet the complex regulatory and data management needs of medical device manufacturers.

Development

Technical Expertise

• Onemo framework supporting both embedded components and standalone SaMD.
Onemo is a powerful development framework designed to support both embedded components and standalone Software as a Medical Device (SaMD). Its robust architecture supports diverse use cases, from controlling hardware in embedded systems to managing complex data flows in standalone solutions. Developed by Cerebellis, Onemo provides a reliable foundation for creating medical software tailored to diverse applications.
• Extensive experience with cloud solutions (ISO 27001, HDS), embedded systems (Raspberry Pi), and local setups (Windows, Linux).
We deliver custom solutions that fit your specific needs, whether you require secure cloud platforms (ISO 27001, HDS), embedded systems like Raspberry Pi, or local setups on Windows and Linux. Using our proprietary Onemo framework, we ensure fast, efficient development while adapting to the unique technical and operational challenges of your project. From cloud-hosted diagnostics to embedded systems for medical devices, our expertise guarantees reliable and flexible solutions tailored to your goals.

Regulatory Compliance

• CE marking readiness from development to documentation.
We help you prepare your software for CE marking, guiding you through every step from development to the required documentation. Cerebellis help you produce your software quality documentation in line with the requirements of your quality system (ISO 13485, IEC 62304, etc.). We focus on creating detailed documentation to prove the system's quality and show how risks, especially those affecting patient safety, are managed. With Cerebellis, you can confidently tackle the challenges of CE marking and bring your medical device to market.
• Execution of rigorous tests aligned with IEC 62304.
At Cerebellis, we perform rigorous testing processes that adhere to IEC 62304 standard, ensuring the highest levels of quality and compliance in software development for medical devices. These tests encompass unit, functional, ergonomic, installation, and performance assessments, simulating real-world conditions to guarantee reliability and safety. Leveraging our proprietary Onemo framework, we streamline the creation of innovative software while maintaining strict adherence to regulatory requirements, giving medical device manufacturers the confidence to bring their products to market efficiently and securely.

Clinical Studies

Powered by Digitalis^®

• Efficient data collection to secure market authorization.
Digitalis^® streamlines and secures data collection to meet the stringent regulatory and clinical requirements of medical device development. This proven eCRF platform, used by startups and international laboratories alike, is designed with exceptional ergonomics and flexibility, enabling seamless adaptation to specific clinical study needs. With integrated modules such as ePRO, eConsent, and DataHub for connected medical devices, Digitalis supports the efficient management of clinical trials and post-market studies.
Discover more at www.digitalis-cdc.com.
• Seamless eCRF implementation and clinical study management support.
Leveraging the Digitalis platform—a proven EDC with advanced functionalities such as device integration and secure health data hosting—we ensure seamless data collection, regulatory compliance, and streamlined study workflows. With a highly configurable architecture and support for industry standards like CDISC, Digitalis adapts to diverse clinical needs. Whether setting up the eCRF, providing expert guidance, or offering continuous support, our team is dedicated to simplifying complexities, reducing time-to-market, and delivering reliable outcomes for your clinical initiatives.

Production

Optimized with Arianis^®

• Ensure quality and traceability throughout production.
Arianis^® is a robust web application designed to streamline inventory and production management for life sciences. It integrates seamlessly into regulated environments, ensuring data integrity and compliance. With Arianis, users can define production protocols, manage equipment and consumables, and generate comprehensive production records, including batch files and certificates of conformity. Its advanced traceability tools allow users to track processes and outputs with precision, reducing risks and maintaining full regulatory compliance (e.g., 21 CFR Part 11). Tailored for small and medium-sized businesses, Arianis offers an intuitive interface that simplifies adoption and boosts productivity.
Discover more at www.arianis.pro
• Comprehensive stock management, batch records, and UDI labeling.
Arianis simplify production management with robust stock control, detailed batch records, and your UDI labeling (Unique Device Identifier). Consumables and equipment are tracked for expiration dates, metrology deadlines, and low-stock alerts in a clear dashboards and email notifications. As production progresses, stock levels automatically update for accurate, real-time traceability. Batch records capture the entire production history, including quality controls and certificates of conformity. UDI labels and other printable labels can be fully customized to align with your coding rules and QMS. This ensures efficient, compliant processes for medical device manufacturers and reduces complexity so clients can focus on delivering quality devices.
• Documentation and templates to streamline software qualification within your QMS.
Cerebellis provides detailed documentation and templates to support the qualification of the Arianis system within your Quality Management System (QMS). These resources are tailored to align with your internal processes and regulatory requirements, offering system specifications, functional test case templates, and regulatory conformity references. By using these tools, clients can document and execute the qualification of Arianis efficiently and in full compliance with their QMS. This approach ensures that Arianis integrates seamlessly into your production environment, supporting traceability, quality control, and regulatory adherence throughout your operations.

Post-Market Clinical Follow-Up

Streamline PMCF with Digitalis^®

• Collect data and generate periodic reports with ease.
The Digitalis platform streamlines data collection for post-market studies and materiovigilance, addressing the rigorous demands of regulated environments. Designed for maximum adaptability and ease of use, it provides real-time access to structured data, dynamic dashboards, and customizable KPIs. These tools allow you to efficiently generate and export periodic reports required for compliance. Trusted by startups and global laboratories, Digitalis ensures data integrity and compliance with industry standards, including secure health data hosting and advanced EDC features. With Digitalis, you can confidently collect and organize the data essential for your clinical evaluations and regulatory submissions.
• Manage multiple devices or models on the same platform.
Digitalis simplifies post-market clinical follow-up by enabling medical device manufacturers to manage multiple devices or models on a single platform. It supports parallel studies and facilitates the generation of detailed cross-device or cross-model reports, providing essential KPIs and insights tailored to clinical and regulatory requirements. With its robust design, Digitalis ensures efficient collection and analysis of clinical data, streamlining PMCF activities. This empowers manufacturers to confirm device performance, maintain compliance, and produce actionable evidence to meet regulatory obligations.