Portal and digital medical technology fair of the largest MedTech cluster in Germany
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 documentation according to MDR/IVDR have increased. The contents of technical documentation are defined in Annex II of the respective regulation. In addition, DIN EN ISO 13485 contains requirements for product or development documentation in the form of a development file or a medical device file. Many of our clients are unsure about what exactly belongs in the technical documentation and how best to manage these various files. The answer from our experienced consultants is often that it is very individual and should be risk-based. It also depends on whether you are a manufacturer or distributor of the medical device. There are requirements for technical documentation both from quality management and from product management or the development team. The technical documentation is, last but not least, the documentation of the final developed product; it includes risk management files, clinical evaluation, product description and much more content. As soon as the product is adapted, relevant parts of the technical documentation must also be revised.
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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.
