20. January 2026
Learn how combination products are correctly submitted to the Notified Body Opinion in accordance with regulations – from PMOA assessment to MDR-compliant documentation.
News
1. September 2025
Alles zur Gammabestrahlung Sterilisation mit Cobalt-60: Ablauf, Vorteile, Anwendungen, Validierung nach ISO 11137 und Einsatz in Medizin, Pharma & Lebensmittel.
1. September 2025
Everything you need to know about EO sterilization: procedures, applications, advantages, validation according to ISO 11135, and current ISO 10993-7 changes for 2025.
1. September 2025
Learn how eBeam sterilization with electron beams works, what advantages it offers, and where it is an alternative to conventional methods.
20. August 2025
Cybersecurity for connected medical devices: meet MDR, NIS2 & FDA requirements, minimize risks, and protect patient safety in 2025.
2. July 2025
Why Professional Support in Writing Scientific Documents for Technical Documentation Is Helpful
27. June 2025
Usability engineering for medical devices: Important regulatory requirements, IEC 62366, UX aspects, and best practices for safe, effective designs.
4. June 2025
Artificial intelligence in medical devices offers great potential – and new obligations.
Discover how the EU AI Act impacts MedTech companies and what it takes to implement AI systems that are safe, compliant, and future-ready.
4. June 2025
Understanding the technical life cycle of AI in medical devices is key to compliance with the EU AI Act. This post explores the stages from development to deployment, highlighting regulatory requirements and best practices to ensure safe and effective AI integration.
2. June 2025
Successful software development starts with solid planning, clean code, and continuous testing. In this post, we share proven tips to streamline your development process, ensure quality, and deliver projects successfully — from gathering requirements to final deployment.
19. May 2025
Learn how medical devices made of materials can be legally distinguished from medicinal products—including the ECJ ruling and MDR regulations. Find out more now!
10. May 2025
What is important in the MDR-compliant clinical evaluation of endoscopes and accessories – requirements, pitfalls, and implementation tips for manufacturers.