Regulatory
On the way to the successful marketing of our OEM products, we take care of all the necessary conformity certifications: In coordination with our customers and from one source.
Our technical documentation is a prerequisite for CE marking or registrations required for access to international markets. We support our customers from the beginning. From risk management to clinical evaluation - we supply the necessary documents and ensure fast and reliable market access.
With our quality management system, we have established and optimized the processes and procedures in the company. We are certified according to EN ISO 13485 as a medical product manufacturer, and for several products we also undertake the manufacturer responsibility ourselves.
Regulatory and legislative requirements are a tremendous drain on the internal resources of many of our customers. With the right strategy, we set the proper course from the very beginning. In this way, we can together overcome the hurdles along the path to product marketing.
As an OEM manufacturer, we supplied all the documents required for CE marking of the vertebroplasty and kyphoplasty set. So nothing stood in the way of market access in accordance with the time schedule.