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
In vitro diagnostics – the importance of in vitro diagnostics for patient management and the health of society
In vitro diagnostics (IVDs) enable early disease detection & precision treatment. Learn how PCR, AI & lab tests improve healthcare & patient outcomes!
Scientific Advice from the Medical Device Expert Panels on SARS-CoV-2-IVDs
The Medical Device Coordination Group (MDCG) requested scientific advice from the European Medicines Agency (EMA) to re-evaluate the classification of SARS-CoV-2 in the context of in vitro diagnostic medical devices (IVDs).
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.