A Clinical Evaluation Assessment Report is required for all manufacturers who want to sell medical devices in the European Union. CEAR demonstrates that your product accomplishes its intended purpose without endangering users or patients, and the manufacturer’s reputation or financial prospects.
Post Market Surveillance is a collection of processes and activities used to monitor the performance of a medical device. Clin-r+ identifies what your Notified Body wants to see in the Post Market Surveillance Plan and PSUR/PMSR.
Performing effective literature searches for EU MDR and other regulations: Overall, the literature search must be exceedingly thorough, consistent, and cover a wide range of search parameters. CLIN-r+ looks at what’s effective.
The first step toward planning a route to EU MDR compliance is to be aware of any compliance gaps. Clin-r+ highlights some common gaps in clinical evaluation reports and technical documentation when transitioning from the MDD to the MDR.
Clin-r+ shares how the QMS underpins this process, how the PMS process sits within this, and divides Post Market Surveillance between reactive and proactive PMS.
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