Medical Device trials with oomnia

Unlock streamlined compliance, enhanced efficiency, cost-effectiveness

Every medical device, from traditional to connected and software-based, demands a tailored approach. At Wemedoo, we specialize in optimizing every phase of your device‘s lifecycle, from pre-market evaluations to post-market surveillance. With a focus on robust data management, we empower manufacturers to surpass regulatory standards and succeed in the market.

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Introducing the medical device product life cycle

Learn how oomnia accompanies you through all market phases

Pre-market evaluation

Prior to market entry, medical device manufacturers undergo essential clinical evaluations to verify product safety, efficacy, and market readiness. This process includes clinical investigations, scientific literature reviews, and preclinical data assessments. Wemedoo‘s oomnia tools streamline these evaluations, covering document, quality, risk, and certification process management. Designed to meet ISO 14155 standards, oomnia also facilitates preparation for ISO 13485 certification.

Post-market surveillance/PMCF

After entering the market, medical device manufacturers must actively monitor their products‘ safety and performance through post-market surveillance. This phase demands systematic data collection, analysis, and interpretation to identify necessary corrective actions and ensure ongoing compliance with regulatory standards. Wemedoo‘s oomnia platform excels in managing this continuous process, offering comprehensive data management tools for effective surveillance and adherence to regulations.

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How oomnia companions your clinical trials

Enhance medical device trials with our unified clinical trial software

oomnia offers an all-in-one solution for data management, regulatory compliance, and efficiency. Our integrated approach is ideally suited to the needs of the medical device industry and easily adaptable to your requirements. Benefit from a unified approach, real-time insights, and the expertise of our team for your Medical Device, Software as a Medical Device (SaMD), and PMCF studies.

Custom-Tailored Approach

oomnia simplifies your compliance journey. Medical devices, whether classical, connected, or software-based, require custom tailored approaches. Enjoy the ease of automated compliant datasets, audit trails, and detailed reporting, all ensuring effortless adherence to regulations throughout your medical device trial.

Clinical Data Management

Manage with ease the vast spectrum of medical device trial
data – from patient insights to device metrics. oomnia seemlessly integrates and handles various data types, including imaging, biometric data, and data extracted from Electronic Health Records (EHRs), ensuring comprehensive and versatile data management.

Post-market surveillance

oomnia enables efficient post-market surveillance with swift collection and analysis of real-world evidence. This ensures ongoing safety and performance monitoring of your medical devices, keeping you compliant and informed.

Effortless collaboration and analysis

oomnia enhances interoperability across healthcare technologies, allowing quick sharing of data, getting updates in real time and making everybody and everything working together smoothly.

Data Protection and Privacy

We are data security and privacy experts. We are ISO 27001 certified and our oomnia software ensures the highest levels of data security and access controls. HIPAA and GDPR compliance is our default standard.

Scalability and Flexibility

With our oomnia software and professional services, we are there as your needs evolve, supporting you from pilot studies to complex international research, as well as PMCF.

Data Analysis and Reporting

oomnia offers advanced data analysis and reporting tools. It facilitates regulatory submissions and empowers your decision-making with state-of-the-art statistical analysis and visualization capabilities.

Excellent data quality

omnia enforces the highest data integrity standards, with robust validation, verification, and cleaning features. Ensure the accuracy and reliability of your trial data, setting a solid foundation for your medical device’s success.

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Join us on our journey to advance clinical research together.

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Explore further trial types

Dive into the full range of research projects supported by oomnia

Embark on a journey through the diverse range of research studies that are seamlessly facilitated by oomnia. Discover various trial types that our solution adeptly supports, highlighting how our technology adapts to different research needs and methodologies. From intricate medication trials to innovative decentralized studies, explore how our software is the backbone of successful and efficient clinical research across multiple domains.