A quality management system (QMS) compliant with ISO 13485 is mandatory for manufacturers of medical devices and IVDs. Without ISO 13485...

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

Product Labeling for Medical Devices is an essential part of the certification process and the technical documentation. It involves...

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

EU AI Act and Medical Devices:  The European regulation for artificial intelligence must also be applied to medical devices. With Prof....

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