Ongoing Safety and Efficacy Monitoring
At confinis, we recognize the critical importance of postmarket surveillance (PMS) for medical devices and combination products. Manufacturers are legally required not only to monitor the ongoing safety and clinical efficacy of these products but also to report any adverse events to the relevant authorities.
Beyond Reactive Measures
While handling complaints is a standard reactive measure, confinis emphasizes the significance of proactive strategies in postmarket surveillance. Our approach extends beyond mere compliance, focusing on preventive measures that ensure continuous product safety and efficacy.
Proactive Postmarket Activities
Our services include:
Customized Surveillance Plans
confinis aids in the development of both general and product-specific postmarket surveillance plans. We tailor these plans to meet the unique needs of each product and manufacturer, ensuring compliance and proactive management of any potential issues.
Hands-On Support for Manufacturers
We often undertake significant parts of the PMS process for our clients. This includes detailed database analyses, exhaustive searches and reviews of relevant literature, and amendments to clinical evaluations to reflect the latest findings.
Why is it important?
Effective postmarket surveillance ensures that medical devices and combination products continue to perform safely and effectively, protecting public health and upholding manufacturer credibility.
