Selected Success Stories
How is a medical device approved? A medical device is an article
An exciting new technology trend that could revolutionize healthcare is the “digital
With growing cross-linking in the digital healthcare sector and the possibilities of medical
In vivo, in vitro, in silico – Medicine is changing and with
Monitoring of medical devices placed on the market
We support you with state-of-the-art simulation technology so that your medical device remains beneficial and safe on the market.
Better objectification of performance and safety as well as possible risks
Efficient evidence generation for post market clinical follow-ups on the function and safety of medical devices
Effective support for defect analysis as well as rectification in case of necessary corrective actions (CAPA) and product failures
According to the latest regulatory requirements, every medical device manufacturer is obliged to proactively and continuously monitor products placed on the market and document their performance. For this purpose, regular reviews of function, safety and quality must be performed and any risks identified.
On the basis of purely clinical observations, it is difficult to generate sufficient evidence in this context. This is especially the case when necessary corrective measures or even product failure are imminent. This is where simulation provides objective data for performance and safety evaluation on a scientific-biomechanical basis. This means that effective countermeasures and product improvements can be achieved even in the event of damage.
In the EU, the Medical Device Regulation (MDR) requires Post Market Surveillance on all devices, but the degree varies based on risk and device type. The MDR also requires a well written post market surveillance plan on all devices.
In the US, Post Market Surveillance is mandated in most cases by the Food and Drug Administration (FDA) for certain class II or class III medical devices. A medical device development requires five phases and the fifth phase is called Post-Market Device Safety Monitoring.
Post market surveillance is extremely important because the device has been studied only in controlled environments. Patients who received the medical device during the clinical study usually fit strict inclusion criteria in the beginning phases, such as: being male, having no chronic health issues or having very specific indications. As the phases progress, the participating population pool grows. But it does not include the general public until post market approval or the post market “phase”. After approval and with the device available to the general population, physicians, healthcare workers, and patients who use this market approved device are able to report if any unseen complications or possibly life-threatening issues arise. Manufacturers are obligated to collect this data because in some cases, approved devices need to be pulled from the market after authorization due to safety concerns. Clinical studies before approval alone simply cannot predict the effect of a medical device on every individual medical device user.
Therefore, it is important to continue to incorporate the benefits of in silico and in silico clinical trials to a greater extent in the future. This makes it possible to cover a larger population from the beginning with less effort and to further increase the safety of medical devices.
Our medical simulation software solutions all generate digital evidence that is documented in a simulation report. This objective data generated with simulation adds another much needed facet to ensure the safety of the medical device and reduces the liability of the medical device manufacturer throughout the Post Market Surveillance period.
Simulation technology continues to advance and become an integral part of clinical studies. Simq also follows recommended Good Simulation Practices (GSP) which is on track to become a good practice quality guideline in the near future, and follows draft guidance from the FDA. When these simulation practices are enforced, we are ready, and therefore, our clients are ready.As mentioned above, Simq software provides a report automatically at the end of simulation, therefore eliminating the need to generate reports manually. We are in V&V40 working groups and always keep the reports up to date. Customized FDA compliant reports are also an available feature in our software solutions. These reports are ready for audits or inspections both internal and external.
There are nuances between the FDA and MDR when it comes to Post Market Surveillance (PMS) and Post Market Clinical Follow-up (PMCF). For the MDR, PMS and PMCF are differentiated. PMS collects many types of data and PMCF collects clinical data to update the clinical evaluation. PMCF is treated by the MDR as a subset of PMS. If the PMS doesn’t present enough data or implies that changes need to be made to the clinical evaluation, PMCF may be required by the manufacturer.
The FDA requires the Post Market Surveillance to include Post Market Clinical Follow-up data, so these two terms (PMA and PMCF) are not differentiated.
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