Fast Tracked PMCF Activities
May 16, 2023
This case study looks at fast tracked PMCF activities and how CLIN-r+ supported one manufacturer with their Clinical Data Acquisition for EU MDR submission from an MDD Certificate based on Equivalence.
Category: Post Market Surveillance
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You Got CE Marked – What’s Next for your Medical Device?
April 18, 2023
The CE mark is a major milestone for most medical devices. It can take a long time to obtain and be a challenging process. CLIN-r+ looks at the manufacturer responsibilities once the CE mark has been granted, update requirements, and more.
Clinical Investigations for Medical Devices and IVD
March 15, 2023
Clin-r+ outlines the requirements and considerations manufacturers should review to ensure that Clinical Investigations they undertake are well researched to ensure a return on investment.
CER, SSCP and PSUR
May 26, 2022
What’s the difference between CER, SSCP, and PSUR? Clin-r+ provides a break-down of the aspiration and content of each report, and explains why the reports are required under the EU MDR.
Summary of Safety and Clinical Performance
February 25, 2022
A Summary of Safety and Clinical Performance (SSCP) is an external document that includes information about a medical device, such as general information about the device, a summary of the clinical data for the device, and possible therapeutic alternatives. Clin-r+ provides information on what is required under EU MDR and how it is used.
Periodic Safety Update Report
February 25, 2022
What is a PSUR? Periodic safety reporting improves medical devices and the advantages they provide to patients. All devices require either a PMSR or PSUR, and the risk associated with the device class determines which report is required, whether it must be reviewed by a notified body (NB), and the frequency of review.
Effective Post Market Surveillance
February 25, 2022
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.
Post Market Surveillance
February 21, 2022
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.
