Portal and digital medical technology fair of the largest MedTech cluster in Germany
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 medical devices in the European market. It is recognized, among other things, in the North American market and also worldwide.
The aim is to minimize risks through conceptual or constructive measures, or - if necessary - appropriate protective measures. If there are residual risks, those affected must be informed or trained using appropriate warnings. In principle, however, the following applies: Any residual risks must be justifiable in relation to the intended useful effect. The protection of health and safety must be guaranteed to a high degree.
We can assist you in all stages of the process, take over or provide support.
We would be happy to help you make your risk management project a success. Contact us, our experts will be happy to advise you.
More information
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.
