I SO 13485 Current Version of the international edition still is the ISO 13485:2016. This is the third edition of the international...

We are very honored to be featured in the newsletter of the Swill network for digital medical regulation" written by Nicklaus Bühler....

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

ColabON's Regulatory Change and Impact Analysis Accelerates and Improves Compliance Assessment Regulatory Change- and Impact Analysis...

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...

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...

International Standards Medical Devices Links and Tipps

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...

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

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...

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...

#harmonisedstandardsmedicaldevices #harmonizedstandardsmedicaldevices #listofharmonizedstandardsmedicaldevices #harmonisedstandardsivds