Hire a Premarket Notification | 510(k) Submission Expert

Dr. Jalal A.

A Ph.D. scholar at Tsinghua University and academic writer by profession.
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Ph.D., Chemistry
Pakistan

I'll write scientific articles or reviews, abstracts, summaries, and assist you in your thesis, format and proofread it. Being a doctoral ...

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Muhammad A.

A Team of Specialists in Creative, Medical, Technical & SEO Writing, Articles/Blogs, Copywriting, Editing & Proo...
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Electrical Engineering
Pakistan

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Expert Life Science's Researcher, writer, and Consultant
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MPhil in Bioinformatics
Pakistan

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Denise A.

Experienced Regulatory Affairs Professional
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Masters of Science
United States

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Master of Technology - Quality Management
India

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USD 200/hr
Bachelors of Science in Biochemistry
Switzerland

I performed inspections and premarket approvals for FDA for 7.5 years. I am now a Senior Consultant operating out of Switzerland. I operate a...

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Stephane G.

Technical innovator - Medical Device Executive - Product development expert
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Ph.D. student
United States

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PhD
United States

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Pakistan

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Medical Degree (MD)
Nigeria

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PhD
India

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Cell and Molecular Biologist | MBA in Medical devices and Healthcare Management | Certified in Regulatory Affairs - GxP
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The London School of Economics and Political Science (LSE)
Germany

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Paul S.

Scientific Editor | Medical Editor, Substantive Editor, Copy Editor | Science Manuscript Editor
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Msc Computer Science
United Kingdom

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Neethu A.

Medical Device Regulatory Specialist - U.S. FDA, 510(k), Specialized at Polymer glove 510(k) documentation
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Applied Electronics
India

Medical Device Regulatory Specialist with years of experience and a deep understanding of European and FDA medical device regulations. Investig...

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Medical writer with 4+ years of experience in clinical evaluation
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Master of Public Health
United States

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https://www.linkedin.com/in/kalidoss-p-09353a65
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Biomedical Engineering
India

Work experience in Medical device regulatory, cybersecurity of the medical device, clinical evaluation report analysis, risk benefit analysis.

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Global Regulatory Affairs Consultant - FDA - Medical Device - Pharma
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Global Regulatory Affairs Certification
Switzerland

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Consult top freelance Premarket Notification | 510(k) Submission experts for help with FDA submissions, technical documents, and more. Get help from top-rated 510k FDA submissions consultants with experience in medical devices, biotech and pharma.

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What Is a 510(k) Submission?

A 510(k) submission enables companies, who want to market their product in the USA, prepare the necessary documents to demonstrate the safety, efficacy and effectiveness of the device intended to be marketed.

What Does a FDA 510(k) Submissions Consultant Do?

A 510(k) submissions consultant prepares premarket approval notifications, also known as a premarket notification 510(k). For devices requiring approval from the FDA before they can be marketed in the USA. 

An FDA 510(k) submissions consultant enables,

  • The device to be cleared by the FDA, declaring it to be legally marketed device
  • The device to be found safe and effective under the appropriate regulation chapters of the FDA
  • Help the business clear FDA quality system inspections anytime after the 510(k) clearance.

Qualifications for a FDA 510(k) Submissions Consultant

FDA 510(k) consultants typically have a degree in the related field of consultation, such as drug regulatory affairs, pharmaceutical technology etc. They hold a highly specialized knowledge of the USA market, and how the various regulatory chapters of the FDA operate.

In addition, 510(k) consultants also possess,

  • Analytical and strategic skills to help them understand the precise steps to gain approval
  • A deep domain knowledge of the regulatory requirements involved in 510(k) submissions
  • Communication and negotiation skills

Benefits of Hiring Freelance 510(k) Submission Specialists

Whilst nigger companies typically have in-house 510(k) submissions experts, smaller organizations can benefit from turning to freelance consultants for their premarket approval consulting requirements.

Hiring freelance 510(k) submissions experts can prove to be,

  • Time-effective, as they are available on-demand when the regulatory process is required
  • Cost-effective, as they typically charge on a more affordable basis than full time employees
  • Highly efficient, as organizations can hire the expert most suited to their requirements from across the globe.

Cost of Hiring 510(k) Submission Consultants

510(k) submission consultants on Kolabtree typically charge from $50/hour to $150/hour for various services, from regulatory document preparation to 510(k) premarket submissions. 

Senior and highly qualified consultants, who might be required throughout the entire submission process might charge upwards of $250/hour for end to end consulting.

How to Post a Project to Hire 510(k) Submission Consultants

Whilst posting a project to hire 510(k) submission consultants, make sure you mention

  • The precise scope and duration of the project
  • The budget you’re willing to spend
  • The exact skills you’re looking for (regulatory consulting, document writing etc)

These details will help you attract proposals from relevant experts on Kolabtree who match your niche requirements.

For further help, checkout this free Kolabtree Whitepaper on 510(k) submissions.