Maintenance for medical devices and IVDs
Diapharm ensures the monitoring and maintenance of medical device and in vitro diagnostic (IVD) conformity throughout the entire product life cycle. We can also offer modular support to ensure individual aspects on request.
In addition to a focus on technical documentation, maintenance of medical devices and IVDs also includes supporting processes, such as:
- Supplier audits and evaluation
- Audits, self-inspection
- Staff training
- Market surveillance
- Conducting literature research
- Adapting risk assessments and clinical evaluations
- Post-market clinical follow-up (PMCF)
Products may have to be changed for any number of reasons, such as new regulatory or normative requirements, marketing needs or production issues. All subsequent product changes are subject to a precisely monitored change control process based on the documentation valid at the time of the declaration of conformity. This process must be planned and implemented with potential risks in mind. We are here to help.
Audits and self-inspections
Diapharm’s audit service ensures that medical devices and IVDs meet high quality standards. We audit suppliers and contract manufacturers on behalf of our clients, plus we provide support during the self-inspection of medical device manufacturers and simulate unannounced audits by notified bodies to check existing process and improve them on an ongoing basis.
Market monitoring: post-market surveillance
Since the changes introduced in Directive 2007/47/EC took effect, market surveillance requirements have been significantly more precise and have included a revision of the clinical evaluation based on post-market surveillance data.
When it comes to post-market surveillance of medical devices, we support our clients by implementing appropriate processes – and by assuming complete responsibility for market monitoring on their behalf:
- Establishment of a vigilance system
- Market surveillance, literature research
- Handling of reports
- Reporting to authorities
- Updating of clinical evaluations
- Planning and coordination of post-market clinical follow-up studies as required