Reduce barrier to entry and expedite your time to market
Bedrock™ is the only all-in-one SaaS cloud-based clinical analysis platform that focuses on usability and regulatory compliance.
Is the Bedrock™ Platform right for you?
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Do you have a clinical analysis algorithm or product that requires FDA approval?
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Do you have limited software engineering resources or software product development expertise?
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Do you have an expedited time to market?
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Do you have a limited understanding of software regulatory requirements?
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Do you have a software analytical solution that is difficult to use?
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Do you have a research analytical solution that is now ready for the clinic?
At Bedrock Digital Solutions, we rely heavily on our regulatory, quality and domain expertise to ensure your product is easy to use, safe and effective, and cybersecure.
Our solution transforms your analysis workflow from fragmented and hard to use technical tools into a cohesive and intuitive clinical cloud application intended for the end user.
➕ Improved patient access
➕ Improved laboratory workflow
➖ Decreased test turn-around time
➖ Decreased need for technical personal
➖ Decreased development cost
➖ Decreased time to market
✔️ Cloud-based analysis platform
✔️ Regulatory compliant & cybersecure
✔️ Integration of multiple devices, software and data
✔️ End-to-end integration with LIMS and physician and patient portals
✔️ Data and analysis management
✔️ Integrates with existing frameworks such as ICA
✔️ Cohesive & intuitive clinical design
✔️ Automated continuous integration and maintenance
✔️ Custom workflows and branding
✔️ Scalable platform and infrastructure
✔️ FDA & EU compliant design history file (technical file)
Regulatory Compliance
- Quality Management System for Medical Devices
- Software Medical Device Development
- Cybersecurity
- Data Privacy
- Artificial Intelligence
- Risk Management
- Human Factors & Usability
Safety/Risk Classification
- SaMD: I–IV
- FDA: basic–enhanced
- IEC: 62304 A–C