As per EU MDR, Post Marketing Clinical Follow-up (PMCF) is a continuous process where device manufacturers need to proactively collect and evaluate clinical data of the device when it is used as per the intended purpose. EU MDR gives more emphasize on PMCF data to confirm the safety and performance of the device throughout its expected lifetime, ensure continued acceptability of identified risks and detect emerging risks based on factual evidence.
MakroCare’s PMCF Capabilities
MakroCare, ISO 14155 certified, is well equipped to support device companies in designing, planning, conducting and reporting of PMCF.
PMCF Strategy / Plan
Development of PMCF strategies based on the device requirements, PMCF plan, study design/type, sample size, evaluation form etc.
PMCF Conduct
Implementation of type of PMCF program, data collection as per the PMCF plan and monitoring
Data Analysis
Analysis of data – interim or final to assess the PMCF objectives
PMCF Report
Preparation of interim or final study reports to be included in the clinical evaluation
| MakroCare’s Features | Benefits to Manufacturers |
|---|---|
| TA focused study design team of medical, clinical and biostats experts | Identifying the right PMCF design and type by considering gaps in clinical data |
| Clinical hypothesis consultation | Developing a PMCF plan and evaluation form objectively based on TA and device requirements |
| Excellent experience in both prospective and retrospective PMCF program design and conduct | Ensuring scientific validity and acceptability of PMCF data by using the right methodology, sample size calculation and statistical significance |
| Relevant technology support to ensure seamless data collection for a different type of PMCF | Cost efficiencies in managing the PMCF program through technology integrated approach |
| Experience teams in PMCF program monitoring, data management, analysis and for writing | Complete end to end program management |
| Integrated approach using services and technology for PMCF program management |
MakroCare’s Experience in Type of PMCF
- Full-fledged PMCF studies
- Gathering clinical experience gained
- Feedback from Users
- Screening of scientific literature
- Screening of other sources of data
- Evaluations of suitable registrie
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