Profile Summary
Dr. Ahram Q.
My professional background is to technically write the Scientific content, assess the researcher in research work related to Bioinformatics and...
Dr. Kurtulus G.
I am a freelance medical, scientific, and technical writer with high-quality researches at Harvard Medical School proven by research papers pub...
Madhu S.
Over 10 years’ experience in Quality and Regulatory Affairs, and technical submissions for a range of medical devices, including Orthopaedics, ...
Adam F.
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...
.jpg)
Denise A.
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, ...
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. Oyinkansola S.
Overview: As a dedicated Medical Doctor and accomplished Research Writer, I bring a unique blend of medical expertise and writing proficiency ...
Dr. Murtaza Najabat A.
I am a biomedical engineer with over 20 years of experience in medical device development and healthcare technology. Apart from academia, I hav...
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. Nadeem A.
• Cell biologist with seven years of academic scientific writing experience • MBA candidate in Medical Devices and Healthcare Management with t...
Dr. Harsh V.
A competent pharma professional with experience in Scientific writing, Regulatory competitive intelligence, DRA, F&D, MSAT and QA. Experie...
Paul S.
I bring over a decade of professional writing, copy editing, and medical editing expertise. Since 2008, I've meticulously edited thousands ...
Jose A.
Behind every successful medical device registration, there is a team of experts working hard to ensure it meets regulatory requirements. As a Q...
Neethu A.
Medical Device Regulatory Specialist with years of experience and a deep understanding of European and FDA medical device regulations. Investig...
Andrew B.
Technical writer with 3 years’ experience executing clinical-regulatory documentation and demonstrated knowledge of EU MDR, clinical evaluation...
Viky Gilles Daniel V.
Guru providing regulatory affairs services to the medical device / medtech, biotech, and pharmaceutical industries. Qualification supported by ...
Kalidoss P.
Work experience in Medical device regulatory, cybersecurity of the medical device, clinical evaluation report analysis, risk benefit analysis.
.jpg)
Laura F.
Results-driven commercial enablement leader with 20 years of healtcare-related experience in marketing, sales, training and product management....
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 and NDA 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 and NDA clause.
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.
Contact experts directly
Speak directly with freelancers and explain your requirements.
100% satisfaction guaranteed
You have to approve the deliverables only if quality meets your expectations. If you arn’t happy, we’ll refund your money.
Project Management
Keep track of files and conversations in the user-friendly Workspace.
Flexible, secure payments
You can choose to pay either a fixed or an hourly fee based on your requirement.
-
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 your Project (Free)
Your project details are safe, secure and visible only to logged-in users.
Get Quotes & Choose Experts
Discuss your requirements in detail with the experts before accepting the final statement of work from Kolabtree.
Collaborate
Pre-pay for your project and work with the expert to get your desired output. Keep track of files and conversations in the user-friendly Workspace.
Job Done!
Approve the deliverables once you're satisfied with the job done.
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.
