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:

  • Planning and Execution of PMCF Studies

    Conducting postmarket clinical follow-up studies to gather additional and ongoing clinical data.

  • Monitoring Competitors

    We actively monitor databases for safety reports on comparable products by competitors, ensuring you stay informed about industry-wide safety trends.

  • Literature Analysis

    Regular review and analysis of current scientific and clinical literature to maintain up-to-date product evaluations.

  • Clinical Evaluations Revisions

    Frequent updates to clinical evaluations based on new data and insights gathered from various sources, including implant registries.

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.