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Post-Market Clinical Follow-Up 

Ensure Simple Continuous Data Collection & Compliance

Navigating the complexities of Post-Market Clinical Follow-Up (PMCF) activities is a nuanced process. Our team at Cliniture provides specialized expertise, offering a complete and tailored PMCF service to assist you in planning these activities, justifying their rationale, executing and reporting them, to ensure their perfect alignment with regulatory requirements.

Cliniture Advantages

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Record of MDR
Audit Success

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WORLDWIDE

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Experience with various

Notified Bodies  

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Subject Matter Experts, Spanning Complex Fields 

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Experience with High- and Low-risk Medical Devices

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Commitment to

Meeting Deadlines

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Dedicated,

Professional & Creative

The Challenge

Post-Market Clinical Follow-Up

Post-Market Clinical Follow-up (PMCF) is conducted after a medical device has been placed on the market and is a vital aspect of the Post-Market Surveillance (PMS) mandated by the EU MDR. PMCF activities aim to gather data and assess the continued safety and performance of the device in real-world clinical settings. They play a critical role in ensuring ongoing device effectiveness and patient safety, informing regulatory decisions, and facilitating improvements in device design and usage.

 

With the implementation of EU MDR, PMCF's importance and requirements have expanded, making it a necessity for most devices lacking a well-established market history. However, its implementation is challenging and requires a future-proofed, cost-effective approach to enable long-term efficient activities and the selection of appropriate data collection methods.  

 

This is where Cliniture can help.

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How Cliniture helps

Our team of clinical and regulatory experts proactively conduct effective and methodical PMCF activities tailored to your medical device that ensure you adhere to the latest regulatory standards. 

  • PMCF strategy and planning (or justification for not conducting PMCF activities, if applicable)

  • Data source identification and collection 

  • Data analysis and interpretation 

  • PMCF evaluation report 

  • PMCF study protocols and reports

  • PMCF ongoing monitoring and updates as needed

  • PMCF study technical documents, including protocol amendments

  • Communicating PMCF findings to stakeholders, including regulatory bodies

“We engaged Cliniture's services to revise clinical evaluation documents and develop PMCF and Clinical Development plans for MDR certification. Lihi and her team were highly motivated and dedicated, and were also very proffesional. They demonstrated an open-minded attitude, and excellent communication skills. Importantly, they adhered to the committed due date, ensuring a timely and efficient process.” 
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Malki Epel, VP QA & RA, Taryag Medical

Our Resources

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