At White Buffalo, we understand the critical importance of Post Market Clinical Follow-Up (PMCF) in the health technology sector. This process is essential for ensuring the continued safety and effectiveness of medical devices after they have been released into the market.
With years of experience in assisting companies developing medical devices and healthcare software, we recognize the necessity of continuous evaluation of these products after they have been released into the market.
Understanding post-market clinical follow-up:
PMCF is a phase of clinical evaluation that occurs after a medical device is available on the market. The primary objective of PMCF is to collect data that supports the ongoing assessment of device safety, performance, and effectiveness. This process involves monitoring the long-term behavior of the device, evaluating its impact on patients, and gathering clinical evidence to support future developments.
What is the goal of PMCF?
The goal of Post-Market Clinical Follow-Up (PMCF) is to ensure the ongoing safety and effectiveness of a medical device after it has been released into the market. It involves continuously collecting and evaluating clinical data, monitoring the device’s performance and any adverse events, and updating its risk assessment. This process helps in identifying any need for immediate corrective actions and supports the overall lifecycle management of the device, ensuring it remains a safe and beneficial option for patients.
The components of PMCF:
The PMCF process includes several key activities:
- Continuous monitoring for adverse events and device deficiencies.
- Gathering feedback from patients and healthcare professionals.
- Analysis of real-world data to assess device performance.
- Updating clinical evaluation reports based on new findings.
How we can help?
At White Buffalo, we provide comprehensive support in conducting PMCF activities. Our services include:
- Strategic Planning: Developing a PMCF plan that aligns with regulatory requirements and business objectives.
- Data Collection and Analysis: Utilizing our clinical expertise to gather and analyze data effectively.
- Regulatory Compliance: Ensuring that all PMCF activities comply with the relevant regulatory standards.
- Reporting: Assisting in the preparation and submission of PMCF reports to regulatory authorities.
In the rapidly evolving field of health technology, PMCF is a crucial step for maintaining the highest standards of patient care and device performance.
With White Buffalo, you gain a partner who not only understands the complexities of PMCF but also shares your commitment to advancing healthcare technology. By leveraging our clinical expertise and regulatory knowledge, we ensure that your medical devices remain safe, effective, and compliant, thus contributing to better patient outcomes and sustained product success.
Ready to elevate the safety and efficacy of your medical devices through expert-led post market clinical follow-up?
Join us at White Buffalo, where our seasoned clinical specialists are dedicated to guiding you through every step of the PMCF process. Let’s ensure your products not only meet regulatory standards but also excel in delivering outstanding patient care. Connect with us today to discuss how we can tailor our expertise to your unique needs and drive success in the healthcare technology landscape.
General Contact information
Email: myynti@whitebuffalo.fi
Phone Number: +358 40 564 8302
Office Address: Jaakonkuja 8, 01400 Vantaa, Finland
Direct contacts for clinical specialists:
Mari Partio
mari.partio@whitebuffalo.fi
+358 40 502 6311
Muhammad Haneefa
muhammad.haneefa@whitebuffalo.fi
+358 40 037 0375
Petteri Tuuttu
petteri.tuuttu@whitebuffalo.fi
+358 40 564 8302