POST MARKET CLINICAL FOLLOW UP
At Hands on Research, we understand that post-market clinical follow-up (PMCF) is an essential part of medical device safety and performance monitoring. That's why we offer PMCF planning services to help you meet the regulatory requirements for post-market surveillance.
Our team of experts has extensive experience in PMCF planning and can assist you in developing comprehensive plans that meet the relevant regulatory requirements, including the Medical Device Regulation (MDR). Our PMCF planning services cover the following areas:
What we offer
Data Collection
We collect data on the safety and performance of your device from a variety of sources, including post-market surveillance, clinical studies, and other relevant information.
PMCF Planning
We develop comprehensive PMCF plans that address the regulatory requirements and the specific needs of your device. Our plans include a detailed description of the PMCF activities, including the study design, data collection methods, analysis, and reporting.
Gap Analysis
We analyse the existing data to identify any gaps in the safety and performance information and to determine the need for additional data collection.
Regulatory Submission Support
We provide ongoing support throughout the regulatory submission process, ensuring that your PMCF plans are complete, accurate, and meet all regulatory requirements.
Experts in developing plans that meet the requirements for PMCF planning and MDR.
Our team of experts has a proven experience with the regulatory requirements for PMCF planning, including the MDR, and can assist you in developing plans that meet these requirements. We are committed to providing high-quality, reliable services that meet the needs of our clients. Contact us today to learn more about our PMCF planning services and how we can help you meet the regulatory requirements for post-market surveillance of your medical device.