IN ONE SIMPLE SENTENCE
Preparing and aligning product documentation to address regulatory requirements.
What is this service?
At this stage, technical, clinical and management evidence must be organized appropriately in the product file and remaining gaps should be identified before submission or review.
GOAL
Reduce avoidable review cycles caused by incomplete documentation and align product claims with the evidence that actually supports them.
What can MICT do here?
Review the file from an evidence perspective, build document matrices, support scientific responses, coordinate technical/clinical/quality teams and prepare the evidence package.
TYPICAL INPUTS
What we usually need to start
- Technical file
- CER and clinical reports
- Risk management
- Test reports
- Labeling and IFU information
TYPICAL OUTPUTS
What this stage can deliver
- Evidence matrix
- Gap / readiness review
- Scientific and technical response support
- Aligned documentation package
- Pre-submission remediation actions
Important terms in plain language
Submission
Formal submission of documentation to the relevant reviewing authority.
Technical File
The collection of technical, safety, performance and clinical documentation for the device.
Claim
A statement made about device performance, benefit or intended use.
Regulatory Support
Expert support for preparing and aligning documentation; it is not a guarantee of approval.
SIMPLE EXAMPLE — BLOOD PRESSURE MONITOR
If a blood-pressure monitor is labeled as suitable for older adults, the evidence package should support that claim.