Our Services
Multi-layered legal requirements lead to varied customer requests.
As a professional consulting firm with a focus on medical technology, BEO BERLIN offers a wide range of services in the various requirement areas of the European Medical Devices Regulation, quality management and the German list of medical aids.
Below you will find an overview of our main areas of activity based on typical questions For further information, simply click on the topics and read on.
Whether it is the preparation of your CE documentation, the registration of your products in national reimbursement systems or support in setting up a customised quality management - we adapt our services to your individual requirements. In addition, we will be happy to assist you with product registration in the register of medical aids and offer training on various topics.
REQUIREMENTS ACCORDING TO?
DOCUMENTS COMPLETE?
ALL UP TO DATE?
REQUIREMENTS ACCORDING TO?
QM
Quality Management
A quality management system includes measures to plan, control and improve the quality of your medical devices to meet regulatory requirements, quality standards and risk management practices and to improve product safety and effectiveness.
DOCUMENTS COMPLETE?
ALL UP TO DATE?
REQUIREMENTS ACCORDING TO?
MDR
Medical Device Regulation
The European Medical Device Regulation EU-MDR 2017/745 regulates, among other things, the manufacture, authorisation, labelling, surveillance and placing on the market of medical devices. The aim is to ensure the safety, quality and performance of these devices.
DOCUMENTS COMPLETE?
ALL UP TO DATE?
REQUIREMENTS ACCORDING TO?
HMV
The list of medical aids is a list of medical-technical aids kept by the statutory health insurance funds in Germany. Following an application procedure, each product is assigned an item number that reflects its intended purpose, properties and characteristics. With the help of this aid number and a medical prescription, the reimbursement of the products is facilitated.
DOCUMENTS COMPLETE?
ALL UP TO DATE?
AREA OF RESPONSIBILITY?
REPRESENTATION NEEDED?
NEED FOR FURTHER TRAINING?
AREA OF RESPONSIBILITY?
BEO FOR YOU
Personnel and Training
Many companies do not have the capacity to fill certain statutory roles. When time or qualified personnel are lacking, consider BEO BERLIN as your external department. Our qualified staff will take on the required roles. In addition, we train your team and bring you up to speed.
REPRESENTATION NEEDED?
NEED FOR FURTHER TRAINING?
How can we help you?
Unsure what to do or how to implement the first regulatory steps? We are happy to support! Simply contact us and we will help you with orientation and implementation.
You know exactly where you need support? Great, then get in touch with our sales team and we will discuss what a cooperation with BEO BERLIN can look like.
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