Overview of the current changes to the Medical Device Regulation (MDR). We collected all helpful data within the ColabON tool. This involved

The impacts of roles in quality system management  that many managers overlook but can significantly slow down your organization. 1️⃣...

The Importance of Effective Labeling Labeling is a critical aspect of medical device development and regulatory compliance. A clear,...

Standards and Regulations for Medical Devices: Not Obstacles, but the Key to Success, Innovation, and Trust Standards and regulations in...

International Standards Medical Devices Links and Tipps

Have your medical devices assessed for compliance and tackle the challenges of the EU-AI Act efficiently. We’re offering up to 3...

SN EN ISO 13485/A11:2021 Medical devices — Quality management systems — Requirements for regulatory purposes Amendment 11 What is the...

In the medical device industry, balancing compliance costs  with the need for speed and innovation is a constant challenge. How does your...

In the highly regulated world of medical devices, staying compliant with ever-evolving regulatory requirements is critical for...

Poor Data Quality lead to High time loss for experts in norm interpretation Very high costs for maintaining traceability High compliance...

The following Promt generated this image: is the image with the vision statement "From Regulation to Registration," using the Colabon...

Save the date! On June 26, 2024, an exciting event on the topic of AI + Regulation will take place at the Kaufmännisches...

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