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.

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.

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

Cliniture Advantages

Record of MDR
Audit Success

WORLDWIDE

Experience with various

Notified Bodies

Subject Matter Experts, Spanning Complex Fields

Experience with High- and Low-risk Medical Devices

Commitment to

Meeting Deadlines

Dedicated,

Professional & Creative

"I had the pleasure of working closely with Cliniture on multiple challenging projects. Lihi’s exceptional problem-solving skills and strong attention to detail were instrumental in the success.

I highly recommend Lihi, Victoria, and the Cliniture team members for their exceptional attention to customer needs, dedication, professionalism, and ability to deliver results. Their capacity to understand and anticipate customer requirements was key to delivering outstanding service."