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Nederlands
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Manfredi Grp is niet beschikbaar tot Aug 28, 2026
“Hi, we are currently on summer holiday. We will respond upon our return! Thanks, The MCG Team”
I will perform US fda medical device strategy and consulting
Manfredi Grp
Level 2
5,0
5,0
Over deze dienst
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.
Maak kennis met Manfredi Grp
Manfredi Grp
niet beschikbaar
FL, USA
Level 2
- Afkomstig uitVerenigde Staten
- Lid sindsjun 2016
- Gem. reactietijd1 uur
- Laatste levering6 maanden
Talen
Engels
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.
Andere Advies over naleving van regelgeving diensten die ik aanbied
Veelgestelde vragen
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 van deze dienst
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M matnick07
Verenigde Staten
Very respectful, professional, insightful, and knowledgable in the FDA regulatory space. Will likely work with Maria again in the near future. Thank you Maria!
Nuttig?S stevebarr2019
Verenigde Staten
Marla did a great job, very happy with the work she did.
M Reactie van de freelancer
Nuttig?T team25
Verenigde Staten
thank you for looking
Nuttig?M martybaggen
Verenigde Staten
Maria provided excellent consultation and was able to answer key questions. Don't hesitate to reach out to her with your FDA-related ambitions.
Nuttig?
Reviews
4 reviews van deze dienst
| (4) | ||
| (0) | ||
| (0) | ||
| (0) | ||
| (0) |
Specificering van de beoordeling
- Communicatieniveau van de freelancer
- Aanbevelingswaardig
- Dienst zoals beschreven
Sorteer op
Meest relevant
M matnick07
Verenigde Staten
Very respectful, professional, insightful, and knowledgable in the FDA regulatory space. Will likely work with Maria again in the near future. Thank you Maria!
Nuttig?S stevebarr2019
Verenigde Staten
Marla did a great job, very happy with the work she did.
M Reactie van de freelancer
Nuttig?T team25
Verenigde Staten
thank you for looking
Nuttig?M martybaggen
Verenigde Staten
Maria provided excellent consultation and was able to answer key questions. Don't hesitate to reach out to her with your FDA-related ambitions.
Nuttig?
