About:
1. 510 (k) Review: Buyer can share the finished 510(k) documents and i will review and provide feedback. If changes are essential, i will explain what and why buyer should make changes. This will also cover the formatting according to e Copy guideline.2. Consultation: It can be done either online or through document where a buyer will mention all the questions and i will answer.
3. 510 (k) Documents: This is a complete package.If buyer want a complete 510 (k) Documents, it can be done. Initially i will require all the technical documents from the buyer to start working on FDA documents. It will be done via regular communication in order to get all the infos. It can take from 30 days up to 3 months.
Note: Normally in companies, this process/project takes minimum 8 months upto 2 years.
Reviews
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