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Regulatory and Quality
Systems Solutions
for the Medical Device Industry |
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510(k) EZ™ |
 “Do-it-yourself”
economy with professional results!
510(k) EZ is a premarket notification outline customized for you. Unlike
“canned” templates, 510(k) EZ organizes the information specifically needed for
your device (including any relevant FDA guidance documents). Also included are
tips for a successful submission. It’s so easy!
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Download
and fill out a simple questionnaire.
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Mail the questionnaire and fee* to Amica Solutions. Be sure to include your
email address.
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Receive your customized outline (Microsoft Word® compatible files) via email.
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Plug in your information, and you’re ready to file!
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Optional Sanity Check™ available – have your prepared submission looked over by
a professional consultant before you file!
*Fees: 510(k) EZ - $1000
510(k) EZ with Sanity Check - $1800
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510(k) Modification Review |
Are you making a change to your 510(k) cleared device? Do you need help
evaluating the change, to determine whether a new 510(k) is necessary? We can
help you evaluate the 510(k) status of a proposed change, and provide
convenient documentation for your change control files. It’s so easy!
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Download
and fill out a simple questionnaire.
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Mail the completed questionnaire and fee** to Amica Solutions.
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Receive your documented evaluation by mail!
**Fee: 510(k) Modification Review -
$500
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Amica Solutions
2300 McDermott Road, #200-207, Plano, TX 75025
Phone: 972-849-5167
E-mail: koakes@amicasolutions.com |
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