Quality Management
Quality Management
A functioning quality management system is the engine of every company. It assigns responsibilities, plans the development, and ensures flawless production of a medical device. Furthermore, an implemented quality management system is the basic prerequisite for placing medical devices on the market in Europe.
Quality management is not only a means to an end. In many companies, the misconception still stands, that quality management must cost a lot of money and cause unnecessary documentation – when in fact, the opposite is true. With an optimized and efficient QM system, costs can be saved in many places: by minimizing errors in production, through the clever selection of suppliers and by the targeted training of employees.
Whether EN ISO 13485, 21 CFR Part 820, GLP or a solution without a formal framework - our experts will help you to set up an efficient quality management system that represents the real added value for your company.
Quality Management
Performance portfolio
News
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.
20 years of medical technology approval
We are celebrating our anniversary. We have been a partner to the healthcare industry for 20 years and support companies with the approval of medical products