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...

Standards and Regulations for Medical Devices are essential to fulfill for CE Registration and Market Approval. Standards and regulations...

International Standards Medical Devices Links and Tipps

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

Regulatory Requirements for Medical Devices Regulatory requirements for medical devices  include all legal, normative, and governmental...

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