About us
Hanseatic. Approachable. Personal.
We see ourselves as true Hanseatic citizens. Our handshake serves as a sign of commitment, and our word carries weight. We meet people as equals – we are appreciative, open-minded and interested, without pigeonholing and prejudices. Our actions are characterized by respect and tolerance and our openness to the needs of the individual.
We believe: business is always conducted between people. We listen, and we want to understand the real needs of our customers, which allows us to serve them as partners and provide tailored and targeted support. The business relationship with our customers is designed for the long term. We approach these partnerships with reliability, integrity and trust, and we strive to complete every project with customers who are not just satisfied, but enthusiastic.
We are a team of individual characters, who all have specific expertise, their own views, ideas and needs, and who are united in working together to keep our ship on the right course.
To this end, we have created a consistent, reliable and cosmopolitan working environment that offers maximum opportunities for development, embodied by a management culture without rigid hierarchies. It is our ambition to create a workplace for each member of our team that corresponds to their nature, personal circumstances, wishes and talents. This allows us to offer the security of long-term planning and design of a workspace that matches the requirements and needs of all our employees’ personal lives.
News
Opportunity and challenge: Regulatory requirements for AI-based medical devices
AI has the potential to revolutionize healthcare and improve the lives of millions of people - but only if it is used safely and reliably.
Common Criteria for Information Technology Security Evaluation
Common Criteria (CC): International IT security standards for medical devices, supported by BSI and BfArM, enhance cybersecurity and trust in processes.
Clinical evaluation of eyeglasses
Both prescription and non-prescription eyeglasses are considered medical devices under the regulatory framework of the Regulation (EU) 2017/745.
Clinical Evaluation for Medical Devices in China
The field of medical devices is rapidly evolving, and as technological advancements continue, so do the regulatory frameworks governing their approval and marketing.