Post-market Surveillance (PMS) & Post-market Clinical Follow-up (PMCF) with Clinical Research by Deloitte
Enhancing trust and decision-making in the medical device lifecycle through post-marketing activities
Post-market Surveillance (PMS) and Post-market Clinical Follow-up (PMCF) are used to demonstrate the safety and efficacy of your medical devices/SaMD under real-world conditions of use, detect unexpected side effects, substantiate performance claims, support marketing and advancement, and build trust. Deloitte supports you in planning and executing post-marketing activities that are ideal for your product(s) to generate real-world evidence for decision-making throughout the product lifecycle.
These post-marketing activities include the collection and analysis of data from sources such as:
With our international and interdisciplinary teams in the life sciences and healthcare sectors, we can help you develop and implement meaningful surveys. Our local employees are familiar with the country-specific healthcare system and have good contacts with physicians and healthcare institutions. They can conduct surveys for you in the local language and monitor external vigilance databases.
Depending on local regulatory requirements, it may be necessary to conduct a post-market clinical follow-up study or registry to collect real-world and/or long-term clinical data on your device. We can help you develop a clinical and regulatory strategy tailored to your needs to collect sufficient data to provide clinical evidence, build confidence and support sustainable growth. Deloitte has an experienced team to run your PMCF studies, handle large volumes of data and support clinical evaluation. Our international teams can also support you with reimbursement submissions.
With Deloitte's digital solution, we can extract and analyze relevant scientific literature and publicly available data from large databases to support your PMS activities and the evaluation of market-related feedback. Publicly available data can also be used to troubleshoot problems and avoid or accelerate corrective and preventive actions (CAPAs).
SaMDs1 are subject to post-market surveillance requirements. The manufacturer should actively and continuously monitor the safety, effectiveness, and performance of the SaMD. Depending on the risk classification of the software, post-market clinical follow-up studies may be required. The unique connectivity of the SaMD facilitates access to real-world performance data, providing additional insight into clinical performance data and allowing the manufacturer to continuously improve the device and develop new claims.
For more information, please visit our Clinical Research overview website. Please feel free to contact us to discuss your specific needs.
