Post Marketing Clinical Follow-Up
DEVICES

Post Marketing Clinical Follow-Up (PMCF)

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

PMCF Strategy / Plan

Development of PMCF strategies based on the device requirements, PMCF plan, study design/type, sample size, evaluation form etc

PMCF Conduct

PMCF Conduct

Implementation of type of PMCF program, data collection as per the PMCF plan and monitoring

PMCF Data Analysis

Data Analysis

Analysis of data - interim or final to assess the PMCF objectives

PMCF Report

PMCF Report

Preparation of interim or final study reports to be included in the clinical evaluation

MakroCare’s Features

  • Tick Mark TA focused study design team of medical, clinical and biostats experts
  • Tick Mark Excellent experience in both prospective and retrospective PMCF program design and conduct
  • Tick Mark Relevant technology support to ensure seamless data collection for a different type of PMCF
  • Tick Mark Experience teams in PMCF program monitoring, data management, analysis and for writing
  • Tick Mark Integrated approach using services and technology for PMCF program management

Benefits to Manufacturers

  • Arrow Identifying the right PMCF design and type by considering gaps in clinical data
  • Arrow Developing a PMCF plan and evaluation form objectively based on TA and device requirements
  • Arrow Ensuring scientific validity and acceptability of PMCF data by using the right methodology, sample size calculation and statistical significance
  • Arrow Cost efficiencies in managing the PMCF program through technology integrated approach
  • Arrow Complete end to end 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 registries

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