Real world data collection tool
Compliance-by-Design
for PMCF & Real-World Evidence
1Survey+ the only platform purpose-built for PMCF and Real-World Evidence which embeds regulatory compliance into every step of data collection. Every dataset, signature, and action is automatically certified, timestamped, and notarized through blockchain, ensuring full traceability and eliminating manual verification loops.
1Survey+ allows manufacturers to generate continuous, high-quality clinical evidence that is:
- ISO 14155-aligned
- Immutable and audit-ready
- Instantly verifiable by regulators and Notified Bodies
Resulting in stronger technical documentation, faster submissions, reduced compliance risk, and real-time confidence in the integrity of your evidence.
The new standard for Clinical Data collection
Engineered
to meet MDR standards
1Survey+ was built to generate Level-4 evidence, aligning clinical methodology, ISO 14155 expectations, and real-time data integrity into a single validated process.
- Designed under clinical and regulatory supervision
- Include sample sizing, validated tools, traceability, and integrity checks
- Appropriate for PMCF, PMS, RWE, and technical documentation updates
From requirements to regulator ready platform in 30 days.
Validated technology plus in house expert methodology generates credible, defensible clinical evidence.
1Survey+ follows a clear and structured workflow which combines 1MED’s clinical methodology, regulatory alignment and digital execution. Each phase designed to ensure data compliance and operational speed.
1.
Requirements analysis
Understanding device claims, risks, evidence gaps and regulatory expectations.
Outcome: Defined objectives and justified methodology.
2.
Survey design
Creation of clinically supervised questions, branching logic and validated scales.
Outcome: A protocol aligned with ISO 14155 and MDR.
3.
Implementation
Platform setup, QR cards, access strategy and configuration of real time checks.
Outcome: A validated digital environment ready for deploy.
4.
Review and testing with the client
Functional testing, logic validation and final adjustments before launch.
Outcome: Full client alignment and operational readiness.
5.
Go live
and report delivery
and report delivery
Data collection, live dashboards, in itinere insights and final structured report.
Outcome: Regulatory-ready evidence for technical documentation.
Interested in finding out what 1Survey+ can do for you?
1Survey+ allows manufacturers to reach every stakeholder involved in post market evidence generation, without user limits or platform constraints.
Distribute surveys to
- Patients
- Clinicians and professional users
- Economic operators
- Distributors and field teams
Flexible access methods
- QR codes
- 1Survey+ Cards for anonymous yet traceable follow up
- Direct links
- Web based survey access on any device
1Survey+ allows manufacturers to:
- Scale PMCF and RWE programs across countries, languages and user types with no additional setup, no licensing hurdles and technology friction
- Evidence generation scales as your product scales and 1Survey+ makes it automatic
1Survey+ THE platform for all post-market and real-world evidence needs.
Supports the full spectrum of PMCF and RWE activities, providing validated, traceable and regulator-ready data regardless of recipient or study type.
- PMCF and PMS programs
- Vigilance and complaint follow-up
- Clinician feedback and usability assessments
- Patient reported outcomes and QoL measures
- Long-term observational follow up for higher risk devices
- RWE generation to support market expansion
- Experience and satisfaction surveys for patients or caregivers
- KOL and surgeon advisory feedback
- Training evaluation and procedure standardization
- Distributor and field support evidence capture
- SSCP updates and technical documentation reinforcement
- Health economic and hospital value analysis data
Tell us what's on your mind.
The more details the better.
Fill out the form and let’s start planning something meaningful together.
