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

Roles and Responsibility: A role is a function of a person.

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

Strategy to select the essential standards and regulations supporting both, development and registration.

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

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