Hire a Premarket Notification | 510(k) Submission Expert

Dr. Ahram Q.

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

My professional background is to technically write the Scientific content, assess the researcher in research work related to Bioinformatics and...

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Dr. Kurtulus G.

Expert with 10+ Years of Experience in Medical, Scientific, Technical and Regulatory Writing
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Ph.D. Biotechnology
United States

I am a freelance medical, scientific, and technical writer with high-quality researches at Harvard Medical School proven by research papers pub...

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Madhu S.

Quality and Regulatory Affairs professional | Expert in CE marking, EU MDR 2017, FDA submissions & lead auditor ISO1...
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Advanced PG Diploma in CR & Regulatory Affairs (APGDCR-RA)
India

Over 7 years’ experience in Quality and Regulatory Affairs, and technical submissions for a range of medical devices, including Orthopaedics, S...

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Adam F.

exFDA Investigator / expert in Medical Device & Combination Product design, manufacturing, and compliance
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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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USD 200/hr
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Denise A.

Experienced Regulatory Affairs Professional
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USD 150/hr
Masters of Science
United States

Hi, I'm Denise! I'm a Regulatory Affairs Professional with over 10 years of experience and a Master's Degree in Regulatory Affairs....

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Sundeep A.

Medical Device, IVD, QMS, CE Certificate, FDA 510(K), EU MDR, MDSAP, ISO 13485, SaMD, PMS, CER , PMCF, Risk Management
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Master of Technology - Quality Management
India

A seasoned professional with a decade of experience, I am a Leader and Speaker in the field of Quality Assurance & Regulatory Affairs, ...

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Stephane G.

Technical innovator - Medical Device Executive - Product development expert
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USD 160/hr
Ph.D. student
United States

R&D executive with a Masters in Plastics Engineering and 20 years of experience in the medical device industry; worked in both large-ca...

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Dr. Oyinkansola S.

Medical Doctor and Writer: Bridging Knowledge and Communication in Healthcare
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USD 40/hr
MPH
United Kingdom

Overview: As a dedicated Medical Doctor and accomplished Research Writer, I bring a unique blend of medical expertise and writing proficiency ...

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Dr. Murtaza Najabat A.

Medical Device Development | Healthcare Technology Specialist | Regulatory Affairs Specialist
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USD 80/hr
PhD in Materials Science
Pakistan

I am a biomedical engineer with over 20 years of experience in medical device development and healthcare technology. Apart from academia, I hav...

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USD 80/hr
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Dr. Geetanjali B.

Research Scientist with experience in Medical Devices, Pre-clinical Research and Writing
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USD 50/hr
PhD
United States

I am a Ph.D. in Bioengineering with expertise in medical device development and innovation, experimental design, data analysis and interpretati...

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Dr. Waqar L.

Auditing, Consulting, Training and Operations Management for International Standards i.e. ISO, BSCI, DIN, MDD, MDR, PPE
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USD 75/hr
PhD
Pakistan

Ten + years of hands-on technical working experience in the manufacturing environment covering Metal, Textiles, Food, Auto parts, Chemical proc...

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Dr. Precious O.

Freelance Medical Writer with 5 year experience in Biomedical/Clinical Research
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USD 25/hr
Medical Degree (MD)
Nigeria

I am experienced in

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Dr. Nadeem A.

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

• Cell biologist with seven years of academic scientific writing experience • MBA candidate in Medical Devices and Healthcare Management with t...

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Dr. Harsh V.

Medical/Scientific/Regulatory/Newsletter/CMC/Dossier/Research/Review/Thesis/Protocol/Report/Article writing & editin...
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USD 30/hr
PhD
India

A competent pharma professional with experience in Scientific writing, Regulatory competitive intelligence, DRA, F&D, MSAT and QA. Experie...

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Paul S.

Scientific Editor | Medical Editor, Python Programmer, Data Analyst | Data Scientist
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USD 50/hr
Python Programming
United Kingdom

I bring over a decade of professional writing, copy editing, and medical editing expertise. Since 2008, I've meticulously edited thousands ...

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Jose A.

Freelance Medical Device professional with over 25 years of experience implementing QMS systems and RA compliance
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USD 175/hr
M.S Clinical Nutrition
United States

Behind every successful medical device registration, there is a team of experts working hard to ensure it meets regulatory requirements. As a Q...

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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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Andrew B.

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

Technical writer with 3 years’ experience executing clinical-regulatory documentation and demonstrated knowledge of EU MDR, clinical evaluation...

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Viky Gilles Daniel V.

Global Regulatory Affairs Consultant - FDA - Medical Device - Pharma
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USD 150/hr
Global Regulatory Affairs Certification
United States

Guru providing regulatory affairs services to the medical device / medtech, biotech, and pharmaceutical industries. Qualification supported by ...

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Kalidoss P.

https://www.linkedin.com/in/kalidoss-p-09353a65
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USD 10/hr
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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Laura F.

Commercial Enablement Leader | Strategic Market Analyst | Expert Launching HighSpot
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USD 190/hr
Bachelors
United States

Results-driven commercial enablement leader with 20 years of healtcare-related experience in marketing, sales, training and product management....

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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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You will receive detailed proposals directly from Kolabtree. These proposals will include a comprehensive Statement of Work (SOW), project fees, milestones, and deadlines.

You can choose to pay either a fixed or an hourly fee based on your scope of work. Pre-pay for the next milestone. You have to approve the deliverables only if the quality meets your expectations. If you arn’t happy, we’ll refund your money.

Kolabtree will share multiple quotations for your project. You have the freedom to accept the quote that aligns with your project requirement and budget. You can get in touch with us in case you want to discuss the fee.

Our T&C include a default confidentiality clause that protects your IP and NDA for added protection.

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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.