top of page


How to Optimize a Quality Management System ISO 13485 that includes Regulatory-Critical Processes?
A quality management system (QMS) compliant with ISO 13485 is mandatory for manufacturers of medical devices and IVDs. Without ISO 13485...
Feb 18
15 views
0 comments


Change History: MDR Medical Device Regulation EU 2017/745
Overview of the current changes to the Medical Device Regulation (MDR). We collected all helpful data within the ColabON tool. This involved
Jan 17
55 views
0 comments


Medical Devices and IVDs: Your Cookbook for the List of Applicable Standards, Regulations & Guidelines
International Standards Medical Devices Links and Tipps
Nov 9, 2024
43 views
0 comments


How do I handle changes in regulatory requirements for medical devices?
Regulatory Requirements for Medical Devices Regulatory requirements for medical devices  include all legal, normative, and governmental...
Sep 6, 2024
11 views
0 comments


The Hidden Risks of Poor Data Quality: Low Degree of Digitization in Medical Device Industry
Poor Data Quality lead to High time loss for experts in norm interpretation Very high costs for maintaining traceability High compliance...
Aug 16, 2024
38 views
0 comments
bottom of page