I3CGLOBAL QARA Team
The I3CGLOBAL QARA (Quality Assurance and Regulatory Affairs) Team writes the technical articles, regulatory guides and educational content on this website. I3CGLOBAL advises medical device, IVD, pharmaceutical, food and cosmetic manufacturers on regulatory documentation, market access and cGMP compliance.
What Does the QARA Team Cover?
Our content explains regulatory requirements and how manufacturers can approach them. Topics include:
- EU IVDR and EU MDR
- US FDA 510(k) and QMSR
- UKCA and MHRA requirements
- CE marking and EU authorised representative requirements
- ISO 13485 quality management systems
Our consultants work from Germany, India, the United Kingdom and the United States. You can meet the people behind I3CGLOBAL on our About Us page.
How Is Our Content Prepared?
QARA Team content is written for manufacturers and regulatory professionals. We aim to refer to the regulation, standard or official guidance behind each requirement, and we update pages when requirements change.
Our content is general information. It is not legal advice, and it does not replace an assessment of your specific device.
Have a Question About Our Content?
To ask about a page or discuss a regulatory project, please contact our team.