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 manufactured and used within EU Health Institutions – In-House Devices (IH-IVD)
In-house IVD: in-house laboratory tests for safe and reliable diagnostics. Find out more about requirements and regulatory specifications!
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.