Medical products
Safety and quality: From production to use
The manufacture, sale and application of medical devices are subject to strict legal regulations. Not only do the devices have to function properly, risks posed by their use must be minimized.
With qualified employees, you focus on safety and quality and minimize the risk of unnecessary delays in the approval process. Take advantage of our seminars to help you keep an overview of the complex laws and ordinances. From the basic seminar for beginners to the special courses, for example, about risk management requirements or international approval for medical devices, we help you in your day-to-day work.
Legal requirements
It goes without saying that German manufacturers of medical devices need access to the key global markets. However, differences in approval processes constantly lead to problems. Within Europe, the legal requirements are harmonized by the respective EC directives. Globally, however, the different requirements of the respective approval authorities must be satisfied. There are often very different from European specifications in this area. In our seminars about the most important international approval processes, we teach you about critical differences and show you commonalities (if there are any).
Patient safety
Users and operators of medical devices have a great responsibility to the patient. Often, the devices take over life-sustaining bodily functions or are used in very sensitive areas. Devices used for diagnosis or monitoring are also essential to recovery and maintaining good health. Arising from this is a special safety philosophy that is reflected in strict legislation and in our special seminars for users and operators of medical devices.
Trust in our expertise
We support you with knowledge from selected specialists with many years of experience. Auditors of the accredited TÜV NORD CERT centre and other specialists who have been active for many years develop the content of courses that is important for you and give you up to date knowledge in our practically oriented seminars.
We will also come to you
You can benefit from In-house training courses which we will fine tune to meet your wishes.
Just contact us and we will be happy to put together a non-binding offer.
