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Post-Market Surveillance 

Gain Comprehensive, Tailored Solutions for Ongoing Compliance

Effective post-market surveillance (PMS) is vital for regulatory compliance. At Cliniture, our knowledgeable staff aids in planning, reporting, and justifying your PMS processes, aligning them seamlessly with Regulation (EU) 2017/745 (MDR) and MDCG guidelines. Whether it's crafting your PMS strategy, writing PMS user survey questionnaires, or drafting comprehensive reports, we deliver an efficient, systematic service.  Acting as an extension of your team, we provide the expertise and resources essential for maintaining compliance standards while optimizing procedures and operational efficiencies tailored to your internal processes.

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 Surveillance

Post-Market Surveillance (PMS) in the medical device industry involves analyzing customer complaints, vigilance system reports, and device data collected after marketing. However, the labor-intensive nature and associated costs of data collection, including literature research and analysis, pose significant hurdles. 

 

Cross-departmental collaboration, applicable forms and establishing standardized procedures are crucial for efficient data exchange.  

 

This is where Cliniture can help. 

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How Cliniture helps

At Cliniture, our industry specialists develop the right PMS strategy and systematic approach to meet the requirements of Regulation (EU) 2017/745 and MDCG guidelines. Whether you are launching a new product, or transitioning to EU MDR, our team is here to help. 

  • PMS strategy & execution

  • PMS plan & procedures

  • PMS data compliance evaluation

  • PMS report and Periodic Safety Update Report (PSUR) compilation and review

  • PMCF activities

  • Vigilance and literature reviews

“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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