No doubt - Post Market Surveillance (PMS) is a key activity during market lifecycle of a device. The need for PMS arises immediately upon commercialization of the device and is a permanently ongoing task.
PMS is a complex process asking for interconnection of a variety of activities and stakeholders. PMS has to be designed to generate information regarding use of the device to expediently identify device design and/or usage problems and accurately characterize the real-world device behaviour and clinical outcomes.
CE plus provides dedicated support to get established efficient and purposeful PMS. This includes:
In addition, we have available data analytics tools in order to streamline the PMS process.
Device Maintenance starts when products have gone through their initial conformity assessment procedures. The Technical documentation as well as the Quality Management System needs to be maintained in a way to ensure continuous compliance with applicable regulatory requirements.
Changes in the regulatory environment can be triggered by e.g.:
However, changes which trigger maintenance activities may also come from various other sources like Post Market Surveillance, Device Design Changes, Vigilance activities and they can lead to changes in the Quality Management System or the Technical Documentation of the device or both.
CE plus is able to provide all-encompassing support for device maintenance after initial conformity assessment in evaluating the impact and implementation of each change in the Technical documentation and/or Quality Management System. In addition, we’re able supporting or leading communications to notified bodies and/or competent authorities.
Our ability to form cross-functional teams offers a wide variety of due diligence services in mergers and acquisitions, and is carefully selected to investigate and deal with specific requirements
Our services include reviews and assessments of:
Through our regulanet® network, we have access to local experts in over 90 countries. These experts carefully consider the requirements for each of the topics listed above, including local needs and/or requirements for existing or potential products and marketing authorizations.