FAQ

1. What is the primary purpose of the tools offered by Regulatory Globe?

• The tools provided by Regulatory Globe are designed to help users get a better understanding of medical device laws and regulations and to support them in evaluating and implementing all necessary requirements.

2. Are the tools suitable for all types of companies?

• Yes, the tools and strategies developed by Regulatory Globe are specifically tailored for startups, small, and mid-sized companies.

3. Does the full version of the MDR and IVDR Gap-Assessment tools include all chapters and annexes?

• Yes, all MDR and IVDR tools have included all chapters and annexes.

4. What kind of regulations do the tools cover?

• The tools cover ISO 13485: 2016, MDSAP, MDR, IVDR and MedDO.

5. How do the tools enhance my understanding of the regulations?

• The tools are designed to offer clarity and support, helping users evaluate and implement all the requirements of the mentioned regulations.

6. Are there any mobile applications associated with these tools?

• Yes, Regulatory Globe has an app available for both Android and Apple devices. The app includes the Complete MDR, Complete IVDR, newly published EU documents, and an MDR/IVDR implementation guide. Furthermore, Regulatory Globe also offers a free available ChatGPT plugin called “Medical Device EU”.

7. How can I get more detailed information about each tool?

• For a deeper understanding of each tool, it’s recommended to visit the website’s “Tools & Services” section and download the test version of the tool or contact Regulatory Globe directly.