Risk management
New technical, clinical or post-market information can change the known risks and controls.
MICT
Medical Institute for Convergent Technologies (MICT)موسسه پیوند هوش درمان (MICT)
MICT is a medical-technology institute focused on bringing clinical research, post-market evidence, data engineering and expert evidence analysis into one operational environment for medical devices.
Our CRO is the clinical-evidence service arm of the institute.
MEDICAL DEVICE CRO
Clinical evidence services for medical devices.
MICT CRO supports medical-device evidence generation across the product lifecycle: preclinical and performance evidence planning, clinical investigation, data management and biostatistics, clinical evaluation, regulatory evidence support, real-world evidence, PMS, PMCF, vigilance, usability and scientific writing.
The demonstration platform uses role-based access, IRC-linked devices and PostgreSQL-backed records.
CRO EVIDENCE WORKSPACE
Clinical → Post-market
Traceable evidence by product, organization and IRC
PRODUCT IDIRC
Device-specific access and evidence
DATA LAYERLIVE
PostgreSQL
participants · complaints · trends
FIRST: WHAT IS A CRO?
An external scientific and operational team for medical-device evidence.
A Contract Research Organization (CRO) performs contracted scientific, clinical, data, statistical and documentation work for a manufacturer or importer.
Simple example
A company has developed a blood-pressure monitor but does not have a complete in-house team for study design, statistics, clinical reporting and post-market follow-up.
14-STAGE PRODUCT EVIDENCE ROADMAP
From an early device concept to post-market clinical intelligence.
The order below is intentionally chronological for learning.
01Evidence strategy02Preclinical & performance03Risk, usability & human factors04Clinical investigation05Clinical data management06Biostatistics07Clinical evaluation / CER08Medical & scientific writing09Regulatory support10Post-market surveillance11Feedback & vigilance12CAPA & effectiveness13PMCF14RWE & registries
ACTIVITIES THAT CONTINUE ACROSS THE LIFECYCLE
Not every activity starts and ends in a single stage.
New evidence can change risk, documentation, regulatory strategy and clinical conclusions at any point.
Regulatory strategy
Regulatory needs should be considered from early development.
Data governance
As evidence grows, data must remain structured, controlled and traceable.
Scientific writing
Nearly every lifecycle stage creates documents that must clearly explain methods, evidence and decisions.
Version control & traceability
Every important claim or conclusion should be traceable to its source.
Privacy & security
Projects involving patient or user information require controlled access and appropriate data protection.
HOW CRO PROJECTS START
Start with one device and one decision.
We first clarify the IRC/device, intended purpose, responsible organization, target population and the decision that the evidence must support. Only then are data sources, endpoints, methods, responsibilities and documents selected.
01
Define the evidence questionWhat must be verified, measured or explained?
→02
Select the evidence sourcePMCF study, complaint data, literature, registry or mixed sources
→03
Analyze, review and documentMethods and conclusions remain linked to source data
→PMCF DEMONSTRATION
Review the evidence before expert interpretation.
The demo contains hundreds of PostgreSQL participant records, longitudinal metrics, subgroup results, data-quality indicators and a live feedback & safety registry. Authorized users inspect those records first; expert evidence analysis is then executed as a separate interpretation layer.
Open PMCF demonstration