External functions
External functions
External Functions

Know-how and expertise

Our consulting services are characterised by extensive know-how and expertise. We offer customised solutions specifically tailored to your company. Instead of using standard tools we work precisely and finely - much like a surgeon with his instruments.

 

EC-REP
EC-REP
The EC-REP represents companies based outside the EU. To do so, it must fulfil certain tasks and requirements. What are these? Learn more.
Read more
Responsible Person (PRRC)
Responsible Person (PRRC)
The requirements and tasks according to Article 15 of the MDR regulation; what is the significance of this position? Learn more.
Read more
Project Management Officer (PMO)
Project Management Officer (PMO)
Efficient structures, compliant work and thoughtful organisation define the scope of our work. We can advise you from conception to implementation.
Read more
Safety Officer for Medical Devices
Safety Officer for Medical Devices
The position of the safety officer has been completely changed. Read here how companies have to proceed in the future.
Read more
Quality Management Representative (QMB)
Quality Management Representative (QMB)
The top management representative is a prominent figure in quality management. Learn more.
Read more
External functions

EU Authorised Representative (EC-REP)

Who represents manufacturers outside Europe in the EU? We are happy to explain the role of the EC-REP, the authorised representative under Article 11 of the European Medical Devices Regulation 2017/745 (MDR) or 2017/746 (IVDR).

Read more
EU Authorised Representative (EC-REP)
External functions

Responsible Person (PRRC)

The Responsible Person, also known as „person responsible for regulatory compliance" (PRRC), plays a central role in the quality management of medical devices. Here you can learn more about their responsibilities and the requirements a manufacturer has associated with them under the MDR / IVDR.

Read more
Responsible Person (PRRC)
External functions

Project Management Officer (PMO)

No off-the-shelf solutions! Instead, customised solutions tailored to your company. That is our promise!  Whether it is the implementation of a new quality management system (QMS) or the preparation for an audit review, our experienced consultants are ready to answer your questions.

Read more
Project Management Officer (PMO)
External functions

Safety Officer for Medical Devices

The Medical Devices Act demanded a "medical device advisor “. This is no longer required as per European Medical Devices Regulation (MDR). Instead, companies are generally entrusted with the corresponding areas of responsibility. What is meant by this, we explain here.

Read more
Safety Officer for Medical Devices
External functions

Quality Management Representative (QMB)

Achieving quality objectives is not an easy task. According to DIN EN ISO 13485 it is necessary to appoint a top management representative for medical devices being familiar with the relevant regulations and responsible for their compliance. Below you will find more details about this position.

Read more
Quality Management Representative (QMB)
Cart