Clinical and Regulatory Support
CEBIS supports medical device companies with clinical, regulatory and evidence-generation activities spanning development planning, pre-market testing coordination, clinical evaluation, regulatory documentation and post-market clinical follow-up.
Support can be aligned to the device, development stage, target market and evidence requirements.
From Development Planning Through
Development Planning
Support clinical and regulatory considerations as the medical device progresses through development.
Pre-Market Testing
Coordinate appropriate laboratory and preclinical testing requirements with qualified external facilities where needed.
Clinical Evidence
Support clinical evaluation and other clinical evidence-generation requirements.
Regulatory Documentation
Support classification rationale and preparation of appropriate technical documentation.
Post-Market Clinical Follow-Up
Support continued clinical evidence generation after market entry where required.
Clinical and Regulatory Considerations Around the Device
Support can include:
- Development planning
- Clinical-development strategy
- Clinical study requirements
- Regulatory planning
- Evidence-generation needs
- Coordination with testing providers
- Clinical and post-market activities
Connecting Device Programs
Testing Requirements
Understand the type of evidence or testing required for the device.
Protocol Definition
Help define the study or testing approach around the intended objective.
Qualified Facility Selection
Coordinate with appropriate research or laboratory providers.
Study Coordination
Support communication and execution across the selected providers and device-development team.
Organizing Clinical Evidence for
Clinical Evaluation Planning
Define the approach for collecting and assessing relevant clinical information.
Clinical Evidence Review
Evaluate available clinical information relevant to the device.
Clinical Evaluation Report
Organize the clinical evaluation into the appropriate reporting structure.
Ongoing Updating
Maintain the clinical-evidence story as new information becomes available where applicable.
Support for Device Classification and
Classification Support
- Review the device and intended purpose
- Consider applicable classification rules
- Support classification rationale
- Align the rationale with appropriate regulatory guidance
Technical Documentation
- Coordinate required device information
- Organize clinical and supporting documentation
- Support compilation of applicable technical-documentation components
- Coordinate input from relevant clinical and regulatory functions
Continuing Clinical Evidence After Market Entry
PMCF Planning
Define the questions and evidence needs based on the device and existing clinical evidence.
Literature Review
Collect appropriate published clinical information.
Surveys & Observational Methods
Gather relevant post-market information where suitable.
Clinical Investigations
Conduct or coordinate additional clinical investigation when required.
Clinical Evaluation Updates
Connect new evidence back into the wider clinical-evaluation process.
Device Studies Connected to Wider CRO Capabilities
Related services can include:
- Clinical Trial & Project Management
- Data Management
- Medical Writing
- Pharmacovigilance / device-safety support where applicable
- Site Management & Monitoring
- Biostatistics
- Regulatory Affairs
- Quality Oversight
Developing a Medical Device?
Tell us about the device, development stage, intended use, target market, existing clinical evidence and support you require.