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
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Strategic and regulatory aspects for combination products
Learn how combination products are correctly submitted to the Notified Body Opinion in accordance with regulations – from PMOA assessment to MDR-compliant documentation.
Sterilization by gamma irradiation
Alles zur Gammabestrahlung Sterilisation mit Cobalt-60: Ablauf, Vorteile, Anwendungen, Validierung nach ISO 11137 und Einsatz in Medizin, Pharma & Lebensmittel.Introduction to EO sterilization of Medical Devices
Everything you need to know about EO sterilization: procedures, applications, advantages, validation according to ISO 11135, and current ISO 10993-7 changes for 2025.E-Beam sterilization
Learn how eBeam sterilization with electron beams works, what advantages it offers, and where it is an alternative to conventional methods.
