I will do 510k documentation fda amazon and premarket submissions medical device

I am an IRCA-approved lead auditor of ISO 9001:2015, and ISO 13485:2016 and have over 20 years of experience in QMS and regulatory affairs. I specialize in creating 510(k) dossiers in compliance with FDA Regulations and submitting them to the FDA. Additionally, I prepare or review relevant regulatory documentation and provide regulatory affairs services for medical devices, food, drugs, and cosmetics for companies seeking assistance. With many years of experience, I have registered over 50 companies and products.

I will:

• Perform facility registration and device listing
• Obtain a DUNS/UFI registration number with the FDA
• Create 510(k) documentation and submit it to the FDA, including reviewer follow-up until approval
• Register medical devices with the GUDID
• Obtain NDC codes; registered drug establishments must list each drug they distribute in the US, and each listed drug is assigned a National Drug Code (NDC).
• Assist with FDA reporting, such as vigilance and incident reporting
• Assist with pre-submissions to the FDA.