Post-Market Surveillance

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:

  • Setting up a PMS strategy for the complete product portfolio
  • Identification of proper sources for re- and proactive search and collection of relevant data
  • expedient evaluation of such information in regard to product performance and safety
  • starting appropriate activities and updating device documentation such as risk management file or clinical evaluations

In addition, we have available data analytics tools in order to streamline the PMS process.

Device Maintenance

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.:

  • Changes in applicable normative elements
  • Changes in applicable regulations
  • Changes with regard to new scientific data related to the device or its technology

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.

Due Diligence

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

  • on distinct product categories
  • in your countries of interest.

Our services include reviews and assessments of:

  • All regulatory matters, including Technical Documentations and their potential
  • First-step red-flag analysis
  • Regulatory resources (staff, equipment, and expertise)
  • Upcoming risks by new regulations
  • Product supply, including QMS aspects and audits
  • Product portfolio and pipelines (gaps, competitors, development plans, etc.)
  • Risk/opportunity assessment for product portfolios
  • Market access to other territories
  • Growth strategies

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.