IN ONE SIMPLE SENTENCE
A roadmap for the evidence needed to support device safety, performance and regulatory requirements.
What is this service?
Before a device enters expensive testing, the team should know what evidence is needed to support its safety, performance and clinical purpose. This stage is the project evidence roadmap.
GOAL
Avoid scattered or unnecessary testing and define which studies, tests and documents the device actually needs.
What can MICT do here?
MICT can review the device type, intended purpose, users, target market and existing documentation, then build a gap list and evidence-generation plan.
TYPICAL INPUTS
What we usually need to start
- Device and technology description
- Intended purpose
- Target users and patient population
- Target market and regulatory pathway
- Existing tests and documentation
TYPICAL OUTPUTS
What this stage can deliver
- Evidence-generation roadmap
- Evidence gap list
- Recommended next studies and tests
- Initial documentation and prioritization plan
Important terms in plain language
Regulatory / رگولاتوری
Formal rules and requirements that govern studies, market entry and continued availability.
Evidence / شواهد
Information used to show that the device is safe, performs as intended and supports its claims.
Gap Analysis
Comparing existing evidence with required evidence to identify what is missing.
Intended Purpose
The exact medical purpose, target population/users and conditions of use for the device.
SIMPLE EXAMPLE — BLOOD PRESSURE MONITOR
For a blood-pressure monitor, we determine whether technical testing is enough or whether reference-method comparison, usability evidence and clinical data are also needed.