Plan for success: IVD Performance Evaluation Process Planning and Report (PER). Due to EU IVDR 2017/746 new requirements are being imposed on IVD manufacturers pursuing CE marking for their devices. Clin-r+ provides insight and guidance in this document.
IVD Performance Evaluation Planning & Report (PER) Read More »
Composing the clinical evaluation report is one of the most difficult tasks when preparing a medical device submission under EU MDR. Clin-r+ has compiled a list of the top five most useful and reliable resources to consult when writing a CER for a medical device.
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.
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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