Muhammad A.
Greetings, Welcome to our hub of professional writing and research, where a dedicated team with over five years of solid experience provides ...
Dr. Ahram Q.
My professional background is to technically write the Scientific content, assess the researcher in research work related to Bioinformatics and...
Hi, I'm Denise! I'm a Regulatory Affairs Professional with over 10 years of experience and a Master's Degree in Regulatory Affairs....
Sundeep A.
A seasoned professional with a decade of experience, I am a Leader and Speaker in the field of Quality Assurance & Regulatory Affairs, ...
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...
Stephane G.
R&D executive with a Masters in Plastics Engineering and 20 years of experience in the medical device industry; worked in both large-ca...
Dr. Geetanjali B.
I am a Ph.D. in Bioengineering with expertise in medical device development and innovation, experimental design, data analysis and interpretati...
Dr. Waqar L.
Ten + years of hands-on technical working experience in the manufacturing environment covering Metal, Textiles, Food, Auto parts, Chemical proc...
Dr. Precious O.
I am experienced in
Dr. Harsh V.
A competent pharma professional with experience in Scientific writing, Regulatory competitive intelligence, DRA, F&D, MSAT and QA. Experie...
Dr. Nadeem A.
• Cell biologist with seven years of academic scientific writing experience • MBA candidate in Medical Devices and Healthcare Management with t...
I am a professional writer, copy editor, and medical editor with more than 10 years of writing and substantive editing experience. Since 2008,...
Medical Device Regulatory Specialist with years of experience and a deep understanding of European and FDA medical device regulations. Investig...
Technical writer with 3 years’ experience executing clinical-regulatory documentation and demonstrated knowledge of EU MDR, clinical evaluation...
Kalidoss P.
Work experience in Medical device regulatory, cybersecurity of the medical device, clinical evaluation report analysis, risk benefit analysis.
Viky Gilles Daniel V.
Guru providing regulatory affairs services to the medical device / medtech, biotech, and pharmaceutical industries. Qualification supported by ...
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.

We take several measures to help you work with full confidence and peace of mind.
Keep your project private
Restrict who can see your project and send you proposals. Invite only specific freelancers to view your project.
NDAs and IP protection
Our T&C include a default confidentiality clause that protects your IP. Sign NDAs for added protection before disclosing project details.
Kolabtree ensures safety and security of your payments and personal information and project details. Kolabtree’s T&C includes a default confidentiality clause. You can also sign NDAs and custom agreements with freelancers for additional protection.
Post your project and receive quotes from relevant freelancers. You can also search for specific freelancers by expertise and invite them to your project. Discuss your project details with each freelancer before picking the one best expert.
We assure you of a 100% satisfaction guarantee, which means you only pay when you’re 100% satisfied with the work delivered. If you aren’t happy, we will refund 100% of your money.
You can choose to pay either a fixed or an hourly fee based on your scope of work. If you’re not sure how much your project costs, you can discuss with freelancers before arriving at a mutually agreed fee.
Kolabtree's terms and conditions prohibit freelancers from claiming ownership of intellectual property, and as a client, you are able to reinforce the message with additional communication, agreements or contracts.
Contact experts directly
Speak directly with freelancers and explain your requirements.
100% satisfaction guaranteed
Pay only once work is delivered and you’re happy with it.
No upfront fees
No minimum commitment or contract required.
Flexible, secure payments
Pay a fixed or hourly fee. We hold your funds securely until you’re ready to pay.
-
Looking for premarket notification 510k consulting services$550.00
-
510k fda submissions consultants needed$450.00
-
Need to outsource 510k submissions consultants$450.00
Post project (Free)
Post your project publicly for all freelancers to view and send you proposals, or interact with specific freelancers privately.
Choose the best expert
Get bids from relevant experts. Interact freely with them before making a hire.
Collaborate
Share files, make audio/video calls and collaborate with your chosen expert.
Complete project
Verify the project is complete to your satisfaction before paying the expert.
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.