That's a very clever idea. I speak quickly and there is a lot of technical jargon. It must be quite a challenge, but this will prepare you well for communicating with English-speaking auditors, inspectors, and other medical device professionals.
Very good suggestion. Thank you. I am presenting a live webinar on 510k software documentation requirements on March 7, 2024, and a webinar on cybersecurity documentation on March 18, 2024. Our cybersecurity work instruction (i.e., WI-007) includes a template for an SBOM. The March 18 webinar will include a brief tutorial on how to use that template and the March 7 webinar will show you how and where to attach the SBOM template once you complete it.
The US agent is responsible for communications between the FDA and the company. If the company is not cooperating with the FDA in the event of a recall, then the US agent will need to assist the FDA with a recall. I have never seen this happen, but it could. The US agent does not have any control over the company. Therefore, the US agent can't be liable for things the company does.
A US Agent can be associated with the facility being registered (e.g., a US sales representative) or they can be independent (e.g., a consultant). In either case, the person must reside int he USA. Therefore, yes an employee of a foreign establishment residing in the US can be a US Agent.
Yes, we offer US Agent services. You can visit our contact us page to request a copy of our US Agent agreement: medicaldeviceacademy.com/contact-us/ Or visit our website specific to those services: fda-us-agent.com/
Great video! This was very clear and concise and strengthened what I already knew and fleshed out several details I was not aware of.
We strive to make the complicated regulations easy to understand. I'm glad you found it clear and concise.
Good educational Info, becca will soon reach you.
Thank you. Looking forward to working with you.
Haha, I am here to practice my listening English. Think you Sir, It's really helpful.
That's a very clever idea. I speak quickly and there is a lot of technical jargon. It must be quite a challenge, but this will prepare you well for communicating with English-speaking auditors, inspectors, and other medical device professionals.
Hey, I think that a good SBOM tutorial or prep for video conference would be amazing
Very good suggestion. Thank you. I am presenting a live webinar on 510k software documentation requirements on March 7, 2024, and a webinar on cybersecurity documentation on March 18, 2024. Our cybersecurity work instruction (i.e., WI-007) includes a template for an SBOM. The March 18 webinar will include a brief tutorial on how to use that template and the March 7 webinar will show you how and where to attach the SBOM template once you complete it.
thank you sir, this has been very useful
Glad it helped. Any suggestions for other related videos?
Thank You Sir for the info.
You're very welcome.
Hey, I love your videos
Thank you. If you have any suggestions for a future video, we love your ideas.
@@MedicalDeviceAcademy see above
Thank you :)
You're welcome!
Is the us agent responsible if something legal happens with the foreign company?
The US agent is responsible for communications between the FDA and the company. If the company is not cooperating with the FDA in the event of a recall, then the US agent will need to assist the FDA with a recall. I have never seen this happen, but it could. The US agent does not have any control over the company. Therefore, the US agent can't be liable for things the company does.
I would like more info
Here's a link: fda-us-agent.com/
No it is not required to have a DUNS number to become a US Agent if you are in the USA.
Does US Agent have to be independent of the registration facility? Can an employee of foreign establishment residing in US be a US Agent?
A US Agent can be associated with the facility being registered (e.g., a US sales representative) or they can be independent (e.g., a consultant). In either case, the person must reside int he USA. Therefore, yes an employee of a foreign establishment residing in the US can be a US Agent.
Hello, are you an agent? I need to renew my FDA registration, can you help me?
Yes, we offer US Agent services. You can visit our contact us page to request a copy of our US Agent agreement:
medicaldeviceacademy.com/contact-us/
Or visit our website specific to those services: fda-us-agent.com/