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 process requirements for product development and product requirements. Why is Product Labeling for Medical Devices an important aspect? Product Labeling for Medical Device is a critical aspect of medical device development and regulatory compliance. A clear, accurate, and comprehensive label is essential for: Patient safety:  Ensuring safe use by

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...