Maintenance for Medical Devices and In Vitro Diagnostics
In addition to managing technical documentation, maintenance for medical devices and IVDs also covers supporting processes such as:
Supplier qualification and evaluation
Audits and self-inspections
Trainings
Post-market surveillance
Literatur reviews
Updates to risk assessments and clinical evaluations
Post-Market Clinical Follow-up (PMCF)
Change Control
Product changes may be necessary for various reasons: new regulatory or normative requirements, marketing needs, or production adjustments. Based on the documentation valid at the time the Declaration of Conformity was issued, all subsequent product changes must follow a controlled change control process.
Audits and Self-Inspections
Audits ensure that medical devices and IVDs meet high quality standards. Diapharm qualifies and audits suppliers and contract manufacturers, supports manufacturers with self-inspections, and conducts mock audits to prepare for Notified Body inspections.
Post-Market-Surveillance
With the application dates of the MDR (May 26, 2021) and the IVDR (May 26, 2022), the requirements for post-market surveillance have become significantly more precise — including the need to update clinical evaluations based on data collected after the product has been placed on the market.
Diapharm supports post-market surveillance by implementing suitable processes or fully managing surveillance activities on behalf of clients:
Establishing a vigilance system
Market monitoring, literature reviews, trend analysis
Processing incident reports
Updating clinical evaluations for medical devices
Updating performance evaluations for IVDs
Preparing regularly updated safety reports (Periodic Safety Update Report — PSUR)
