510K for Syringe Need Support

Hi ,

We need someone qualified who can support us in the preparation of 510 K Documentation for syringes.

We are already registered on the FDA portal.

Link: [login to view URL]

We would like to prepare 510K for Syringes as attached.

We need help in the preparation of the following documentation

1. Complete 510(k) submission in electronic eCopy certified format in accordance with FDA guidance (on a single CD, DVD, or flash drive). All files must be in . PDF format and submitted in NON-Volume structure - Need support

2. Complete 510(k) submission fully paginated with a Table of Contents - Need support

3. Completed Traditional 510(k) RTA Checklist [with all page numbers indicated] -

All submitted test reports must have an accompanying summary table outlining the results and test comparisons to the predicate device - ( We can get the Lab Report )

4. Affirms the subject submission does not contain clinical data

5. Post submission support, assist in responding to additional information requests from FDA

Kemahiran: Penulisan Perubatan

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Tentang Majikan:
( 0 ulasan ) Salem, India

ID Projek: #30578969

4 pekerja bebas membida secara purata ₹28125 untuk pekerjaan ini


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