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English
$
USD
I will perform US fda medical device strategy and consulting
Manfredi Grp
5.0
5.0
About this gig
We're here to provide you with most robust US FDA regulatory classification for your new or legacy device so you can be confidently ready for product launch. See my bio of over 10 successful years in the consulting for industry serving start ups, top industry clients Cook Medical, Stryker & Johnson & Johnson. Experience includes complex class III devices working in the implant space, blood filtration, laser systems, software as a medical device and AI/ Machine Learning. Welcome all types of medical devices, or if you are wondering if your device even classifies as a medical device, we can help with that too!
Pick the right package that is based on your current needs. We are happy to create a custom Gig for you.
Looking forward to serving you with all your regulatory Medical Device needs.
Get to know Manfredi Grp
Manfredi Grp
FL, USA
- FromUnited States
- Member sinceJun 2016
- Avg. response time1 day
- Last delivery4 months
Languages
English
Welcome to the Manfredi Consulting Group, an American Company, led by our seasoned Global Regulatory expert & CEO, Maria. We are "Fiverrs Choice" for global regulatory intelligence for medical device, cosmetic and OTC Drug companies. With a rich background of experience, spanning over a dozen years, our expertise in regulatory affairs is unparalleled. We specialize in navigating the complex landscape of global regulations, turning intricate policies into actionable, straightforward strategies for your business, fast! Book us today to help you maintain regulatory compliance.
Other Regulatory Compliance Consulting Services I Offer
FAQ
Do you analyze any type of medical device?
Yes, even if its not yet marketed any where in the world yet, I can help you determine classification and strategy.
What about a combo drug and device? or IVD?
No, that would be a seperate gig, please message me.
What about my whole line up of devices and components?
This Gig is for one device, not a system. Please message me first.
What if I know nothing about Regulatory or Medical Devices, can you still help me?
Yes! I have a knack in breaking down strategy to basic terms for the CEOs and the day-to-day folks can understand. Easy to digest knowledge, never complicated. I am happy to walk through my assessment via zoom once it's done as well. Whatever helps you and your company.
Can you help me write the submission and submit this for us?
That is a separate gig, please contact me.
Our information is proprietary, will you sign an NDA if requested?
Yes, I totally understand why confidentiality is important. Your project details are kept confidential and never shared with any other clients. Feel free to send me the NDA before we get started. You can message me with the attachment as well.
Reviews
4 reviews for this Gig
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| (0) | ||
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Rating Breakdown
- Seller communication level
- Recommend to a friend
- Service as described
Sort By
Most relevant
M matnick07
United States
Very respectful, professional, insightful, and knowledgable in the FDA regulatory space. Will likely work with Maria again in the near future. Thank you Maria!
Helpful?S stevebarr2019
United States
Marla did a great job, very happy with the work she did.
M Seller's Response
Helpful?T team25
United States
thank you for looking
Helpful?M martybaggen
United States
Maria provided excellent consultation and was able to answer key questions. Don't hesitate to reach out to her with your FDA-related ambitions.
Helpful?
Reviews
4 reviews for this Gig
| (4) | ||
| (0) | ||
| (0) | ||
| (0) | ||
| (0) |
Rating Breakdown
- Seller communication level
- Recommend to a friend
- Service as described
Sort By
Most relevant
M matnick07
United States
Very respectful, professional, insightful, and knowledgable in the FDA regulatory space. Will likely work with Maria again in the near future. Thank you Maria!
Helpful?S stevebarr2019
United States
Marla did a great job, very happy with the work she did.
M Seller's Response
Helpful?T team25
United States
thank you for looking
Helpful?M martybaggen
United States
Maria provided excellent consultation and was able to answer key questions. Don't hesitate to reach out to her with your FDA-related ambitions.
Helpful?
