Portal and digital medical technology fair of the largest MedTech cluster in Germany
Clinical evaluations of medical devices mean: The objective analysis and evaluation of clinical data on a specific medical device. The aim of the assessment is to demonstrate the performance and safety of the medical device in use.
The assessment is carried out using clinical data from the scientific literature or data from clinical trials.
The clinical evaluation is part of the conformity process for medical devices, which leads to the CE marking. The clinical evaluation is part of the technical documentation or the medical device file. It is updated at regular intervals after the medical device has been placed on the market - taking into account the results of market observation and experiences with the medical device.
We prepare these documents independently on your behalf. The qualifications of our processors guarantee a technically sound assessment of the results.
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Support in the creation of technical documentation for medical devic...
Every medical device, including active and non-active medical devices, implantable medical devices and in-vitro diagnostics, is described in technical documentation. The requirements for technical doc...
No problem: Independent clinical evaluation of medical devices
What is it about: Clinical evaluations of medical devices mean: The objective analysis and evaluation of clinical data on a specific medical device. The aim of the assessment is to demonstrate the per...
The audit: No problem if you are prepared.
What is it about: An audit (or audit) examines whether the processes meet all relevant legal requirements and guidelines as well as valid standards. Audits are carried out by specially trained people...
A quality management system - get professional help!
QiP GmbH helps its clients to set up, certify and further develop a quality management system in accordance with DIN EN ISO 13485 , DIN EN ISO 17025, DIN EN ISO 62304, DIN EN ISO 9001 and others. The...
Post-market surveillance and vigilance for medical devices - a task...
What is it about: Market observation, or post market surveillance (PMS), refers to the proactive monitoring of the medical device market. The MDR/IVDR obliges manufacturers to monitor their product af...
Risk management - an important part of survival
What is it about: Functioning risk management is a mandatory requirement for all medical devices. DIN EN ISO 14971 is assigned to the area of medical technology and regulates risk management for medic...
Become a digital exhibitor yourself in the online portal of the largest and best-known MedTech cluster region in Germany and inform the world of medical technology about your products and services as well as about news, events and career opportunities.
With an attractive online profile, we will help you to present yourself professionally on our portal as well as on Google and on social media.
