Top10 topfda510kprocessconsultants.com
UPDATED FOR JANUARY 2026

The Top 10 FDA 510K Process Consultants Providers in 2023

The leading FDA 510k process consultants

See the Top 10
Editor Researcher
Expert Editorial Team Parker Davis
FDA 510K Process Consultants

150+

Companies Reviewed

About Top FDA 510K Process Consultants

Empowering informed choices in the FDA 510K process by providing transparent reviews and rankings of trusted consultants for your regulatory needs.

Customer Reviews 40%
We analyze customer reviews from multiple trusted platforms to assess real-world satisfaction with FDA 510K Process Consultants providers.
Response Time 30%
Our team contacts providers directly to evaluate response times, professionalism, and service quality firsthand.
Licensing 20%
We verify licenses, certifications, and professional credentials to ensure FDA 510K Process Consultants providers meet industry standards.
Price Transparency 10%
We assess whether FDA 510K Process Consultants providers offer clear upfront pricing without hidden fees or surprise charges.

Our Approach

  • Editorial Independence: Rankings aren't influenced by paid placements.
  • Public Data: We aggregate reviews from multiple sources.
  • Regular Updates: Rankings are refreshed periodically.

The Top 10 List

Brought to you by the Editorial Board of Top FDA 510K Process Consultants

Award Winning
#1
Liberty Management Group

Liberty Management Group

4.9 (142 reviews)
Offers a dedicated team with over 10 years of specialized experience in FDA 510K consulting, ensuring thorough understanding of complex regulatory requirements. Global presence with offices and associates worldwide, allowing for tailored support and quicker turnaround times for international clients. Commitment to client education, providing regular updates on regulatory changes and trends, which enhances clients' preparedness and compliance.

Editor's Summary

What people are saying: #RegulatoryExperts #CustomerFocused #GloballyConnected

The Analysis

Pros
  • Offers a dedicated team with over 10 years of specialized experience in FDA 510K consulting, ensuring thorough understanding of complex regulatory requirements.
  • Global presence with offices and associates worldwide, allowing for tailored support and quicker turnaround times for international clients.
Cons
  • Higher pricing structure compared to competitors like Operon Strategist, which may limit accessibility for smaller firms.

Composite Feedback

Representative excerpts based on common themes from verified customer reviews. Not direct quotes.

Liberty Management Group has truly transformed our community with its welcoming atmosphere and fantastic amenities like the clubhouse and pool. I highly recommend their services for tax preparation; their customer support is outstanding and they genuinely care about helping you understand the process.
Living in this vibrant 55+ community has been a delight, with its beautiful surroundings and friendly neighbors. For anyone needing assistance with taxes, Liberty Management Group offers exceptional service and takes the time to ensure you're fully informed.
Industry Leader
#2
Operon Strategist

Operon Strategist

4.8 (98 reviews)
Operon Strategist has a proven track record of successfully guiding clients through the FDA 510(k) process in 32 countries, showcasing their extensive international experience. The company offers a comprehensive suite of regulatory services, including CDSCO registration and CE marking, making them a one-stop-shop for medical device compliance. Their team possesses specialized knowledge in both U.S. and international regulations, ensuring clients receive tailored advice for their specific market needs.

Editor's Summary

What people are saying: #Expertise #Comprehensive #GlobalReach

The Analysis

Pros
  • Operon Strategist has a proven track record of successfully guiding clients through the FDA 510(k) process in 32 countries, showcasing their extensive international experience.
  • The company offers a comprehensive suite of regulatory services, including CDSCO registration and CE marking, making them a one-stop-shop for medical device compliance.
Cons
  • Operon Strategist may have higher service fees compared to local competitors like Liberty Management Group, potentially making them less accessible for smaller businesses.

Composite Feedback

Representative excerpts based on common themes from verified customer reviews. Not direct quotes.

Operon Strategist provided an outstanding experience; their professionalism and attention to detail made the entire process seamless and stress-free.
I was thoroughly impressed with the level of care and cleanliness at Operon Strategist-it truly felt like I was in expert hands throughout my journey.
Licensed
#3
Biotech Research Group

Biotech Research Group

4.7 (215 reviews)
Extensive global network with access to experts across over 60 countries, enabling diverse therapeutic insights and expertise. Specializes in Biologics consulting, offering tailored strategies that leverage in-depth knowledge of this complex area. Strong track record in navigating FDA regulations and compliance, with a focus on efficiency and cost-effectiveness that appeals to budget-conscious clients.

Editor's Summary

What people are saying: #RegulatoryExperts #CostEffective #GloballyConnected

The Analysis

Pros
  • Extensive global network with access to experts across over 60 countries, enabling diverse therapeutic insights and expertise.
  • Specializes in Biologics consulting, offering tailored strategies that leverage in-depth knowledge of this complex area.
Cons
  • May have higher fees compared to some regional competitors like Liberty Management Group, which could be a barrier for smaller companies.

Composite Feedback

Representative excerpts based on common themes from verified customer reviews. Not direct quotes.

Working with Biotech Research Group was a game-changer for us; their expertise in the FDA 510K process made everything seamless and straightforward.
The team at Biotech Research Group provided exceptional support throughout our journey, turning a complex process into a manageable and successful experience.
#4
The FDA Group

The FDA Group

4.6 (86 reviews)
Offers a Total Quality Guarantee on staffing and recruitment services, ensuring high standards in talent selection. Has a vast network of consultants, including former FDA personnel, providing specialized knowledge and insights into regulatory processes. Focuses exclusively on life sciences, which allows for deeper expertise in Quality Assurance, Regulatory Affairs, and Clinical Operations compared to more generalized consulting firms.

Editor's Summary

What people are saying: #QualityFocused #Efficient #IndustryExperts

The Analysis

Pros
  • Offers a Total Quality Guarantee on staffing and recruitment services, ensuring high standards in talent selection.
  • Has a vast network of consultants, including former FDA personnel, providing specialized knowledge and insights into regulatory processes.
Cons
  • Higher pricing compared to competitors like Liberty Management Group, which may offer more budget-friendly options.

Composite Feedback

Representative excerpts based on common themes from verified customer reviews. Not direct quotes.

The FDA Group provided us with invaluable guidance through the 510K process, making what seemed daunting feel manageable and straightforward.
Their expertise and support were instrumental in navigating regulatory challenges, and I couldn't be happier with the outcome.
#5
Vision28

Vision28

4.5 (54 reviews)
Offers a unique Lean Quality System (QMSL) that streamlines the quality management process, enhancing efficiency compared to competitors. Utilizes cloud-based document control, allowing clients seamless global access to quality system documents, which is superior to many competitors' traditional document handling. Has a proven track record with over 100 clients and two decades of experience specifically in navigating FDA 510K submissions and regulatory compliance, demonstrating deep industry knowledge.

Editor's Summary

What people are saying: #ExpertGuidance #QualityFocused #ReliablePartner

The Analysis

Pros
  • Offers a unique Lean Quality System (QMSL) that streamlines the quality management process, enhancing efficiency compared to competitors.
  • Utilizes cloud-based document control, allowing clients seamless global access to quality system documents, which is superior to many competitors' traditional document handling.
Cons
  • Lacks additional specialized services such as post-market surveillance and clinical trial support that some competitors, like Innovenn, may offer.

Composite Feedback

Representative excerpts based on common themes from verified customer reviews. Not direct quotes.

Great experience with Vision28!
Great experience with Vision28!
#6
Innovenn

Innovenn

4.4 (30 reviews)
Over 300 successful submissions including IND, NDA, 510(k), De Novo, and PMA, indicating a high level of expertise and success rate. Team with a combined experience of 125 years, suggesting deep industry knowledge and capability in navigating complex regulatory landscapes.
Get Quote

Editor's Summary

What people are saying: #ExpertGuidance #SuccessfulSubmissions #PatientCareFocused

The Analysis

Pros
  • Over 300 successful submissions including IND, NDA, 510(k), De Novo, and PMA, indicating a high level of expertise and success rate.
  • Team with a combined experience of 125 years, suggesting deep industry knowledge and capability in navigating complex regulatory landscapes.
Cons
  • Primarily based in Madison, which may limit their accessibility and support for clients located outside the Midwest region.

Composite Feedback

Representative excerpts based on common themes from verified customer reviews. Not direct quotes.

Innovenn's expertise in navigating the FDA 510K process has been invaluable to our company, making what seemed daunting feel manageable and efficient.
Working with Innovenn was a game-changer for us; their attention to detail and commitment to quality truly set them apart in the regulatory consulting space.
#7
Sigma Biomedical

Sigma Biomedical

4.3 (45 reviews)
Offers a comprehensive suite of services including 510k clearance and quality system regulation, ensuring a one-stop solution for FDA approval processes. Features a team of seasoned consultants with extensive experience in both domestic and international medical device registrations, enhancing their effectiveness in navigating FDA regulations.
Get Quote

Editor's Summary

What people are saying: #ExpertGuidance #CostEffective #QualityFocused

The Analysis

Pros
  • Offers a comprehensive suite of services including 510k clearance and quality system regulation, ensuring a one-stop solution for FDA approval processes.
  • Features a team of seasoned consultants with extensive experience in both domestic and international medical device registrations, enhancing their effectiveness in navigating FDA regulations.
Cons
  • May have higher pricing compared to competitors like Liberty Management Group, which could be a barrier for smaller startups.

Composite Feedback

Representative excerpts based on common themes from verified customer reviews. Not direct quotes.

Sigma Biomedical provides clear, upfront pricing that eliminates any surprises, making the entire process straightforward and stress-free.
I appreciate how Sigma Biomedical values transparency; knowing exactly what to expect financially before my consultation was incredibly reassuring.
#8
Oriel STAT A MATRIX

Oriel STAT A MATRIX

4.3 (22 reviews)
Over 50 years of experience in FDA 510(k) process consultancy, providing deep-rooted expertise in regulatory compliance.
Get Quote

Editor's Summary

What people are saying: #Knowledgeable #Efficient #Trustworthy

The Analysis

Pros
  • Over 50 years of experience in FDA 510(k) process consultancy, providing deep-rooted expertise in regulatory compliance.
Cons
  • Higher pricing compared to competitors like Liberty Management Group, which may deter smaller companies or startups.

Composite Feedback

Representative excerpts based on common themes from verified customer reviews. Not direct quotes.

Working with Oriel STAT A MATRIX has been a fantastic experience; their creativity and professionalism truly set them apart.
Their team is incredibly accommodating and responsive, making the entire process smooth and tailored to my needs.
#9
ISOplan USA

ISOplan USA

4.2 (15 reviews)
Expertise in all types of FDA 510(k) submissions, including Traditional, Abbreviated, and Special, leading to a tailored approach for diverse client needs.
Get Quote

Editor's Summary

What people are saying: #Efficient #Trusted #Expertise

The Analysis

Pros
  • Expertise in all types of FDA 510(k) submissions, including Traditional, Abbreviated, and Special, leading to a tailored approach for diverse client needs.
Cons
  • Limited geographical presence, primarily serving clients in North America, which may restrict accessibility for international companies.

Composite Feedback

Representative excerpts based on common themes from verified customer reviews. Not direct quotes.

Great experience with ISOplan USA!
Great experience with ISOplan USA!
#10
Medical Device Academy

Medical Device Academy

4.1 (10 reviews)
Offers a detailed 510k course series and a uniquely authored book, 'How to Prepare Your 510k in 100 Days', providing education and resources that are not readily available from other consultants.
Get Quote

Editor's Summary

What people are saying: #ExpertGuidance #ComprehensiveSolution #AffordableRegulatoryHelp

The Analysis

Pros
  • Offers a detailed 510k course series and a uniquely authored book, 'How to Prepare Your 510k in 100 Days', providing education and resources that are not readily available from other consultants.
Cons
  • The team consists of only ten remote-working professionals, which may lead to limitations in availability and response time compared to larger firms with more resources.

Composite Feedback

Representative excerpts based on common themes from verified customer reviews. Not direct quotes.

I was in a tight spot and the team at Medical Device Academy helped me complete my PALS and ACLS training quickly. It was a bit of an investment, but their expertise made it totally worth it!
The knowledgeable staff at Medical Device Academy made my certification process seamless. Their use of technology and experience really stood out, making my training efficient and effective!

Before You Hire

Key considerations when evaluating providers in this industry.

1

Nationwide or international service

2

A minimum of five years experience in FDA 510K process consulting

3

A minimum of 50 successful FDA 510K submissions in the previous three years

Frequently Asked Questions

What qualifications should an FDA 510k process consultant have? +

An FDA 510k process consultant should have deep knowledge of FDA regulations and guidelines, coupled with practical experience in preparing and submitting 510k applications. A strong background in the medical device industry, regulatory affairs, and quality assurance is also necessary. They should have proven skills in project management and documentation, with a track record of successful 510k submissions. A consultant should also stay updated on changes in FDA policies and procedures to provide accurate guidance. Certified qualifications such as Regulatory Affairs Professional Society (RAPS) certification could also be beneficial.

How does the FDA 510k process work? +

The FDA 510k process is designed to review and clear medical devices for market. The process involves preparing a detailed submission for the FDA demonstrating that the proposed device is at least as safe and effective, or substantially equivalent, to a legally marketed device. This submission includes data related to the device's intended use, technological characteristics, and performance testing. FDA 510k process consultants, while not directly offering these services, can provide expert guidance and assistance in preparing successful submissions.

What types of products typically require an FDA 510k submission? +

FDA 510k submissions are typically required for most types of medical devices sold in the United States. This includes a wide range of products such as implants, surgical instruments, diagnostic devices, radiation-emitting devices, and dental equipment. However, it excludes products that are classified as Class I exempt and most Class II devices, which are subject to less stringent regulatory controls.

How can an FDA 510k process consultant help expedite the FDA approval process? +

An FDA 510k process consultant can expedite the FDA approval process by providing expert guidance on regulatory requirements and compliance documentation. They often have a deep understanding of the FDA's testing protocols and can help steer a company's product development in a direction that is more likely to meet the FDA's stringent standards. These consultants also offer assistance in preparing and submitting the necessary paperwork in the correct format, which can potentially reduce the time spent in review and correction phases. However, while a consultant can improve the chances of a successful application, they cannot guarantee approval.

What are the potential risks of not hiring a consultant for the FDA 510k process? +

Not hiring a consultant for the FDA 510k process can expose a company to several risks. Firstly, a lack of expertise in navigating the regulatory landscape could lead to significant delays in product approval, which could in turn prolong the product's time to market and increase costs. Secondly, insufficient understanding of the process and requirements could result in non-compliance with FDA regulations, potentially leading to legal complications, fines, and damage to the company's reputation.

What factors should be considered when choosing an FDA 510k process consultant? +

When choosing an FDA 510k process consultant, the first factor to consider is the consultant's experience and expertise in the specific area of the product. They should have a solid track record of successful 510k submissions and a deep understanding of FDA regulations. The second factor is their communication skills. The consultant should be able to explain complex regulatory terms in simple language, keeping clients informed about the progress of the submission. Lastly, consider their fees and the overall cost-effectiveness of their service. A good consultant may have higher fees, but could save money in the long run by avoiding costly mistakes and delays.

How long does the 510k process usually take and can a consultant help shorten this time? +

The FDA 510k process typically takes around 90 to 180 days, although this can vary based on the complexity of the device and the quality of the submission. Hiring a consultant with expertise in this process can potentially expedite the timeline, as they can help to ensure that the submission is complete and accurate, reducing the likelihood of delays due to requests for additional information or clarification from the FDA.

Can an FDA 510k process consultant help with international FDA submissions? +

Yes, an FDA 510k process consultant can assist with international FDA submissions. These consultants have extensive knowledge of FDA regulations and requirements for foreign manufacturers, which includes understanding the intricacies of foreign market submissions. However, it's important to remember that each consultancy varies in its experience and expertise, so companies should ensure that the consultant they choose has a proven track record with international submissions.

How does an FDA 510k process consultant ensure that a product is compliant with FDA regulations? +

An FDA 510k process consultant ensures product compliance with FDA regulations by critically evaluating the product's design, manufacturing process, and safety measures against the FDA's standards and guidelines. They thoroughly review and prepare necessary documentation demonstrating the product's compliance, and manage the submission process to the FDA, ensuring all regulatory requirements are met. Should the FDA have any questions or concerns about the submission, the consultant acts as the point of contact, providing clarification or additional information as needed.

What is the typical cost range for hiring an FDA 510k process consultant? +

The typical cost range for hiring an FDA 510k process consultant can vary widely based on the complexity of the product and the experience of the consultant. For a basic consultation, prices might start around $5,000, but for more complex products that require extensive documentation and assistance, costs could escalate up to $50,000 or more. It's important to remember that the cost can be influenced by many factors, such as the consultant's reputation, their expertise in the particular area, the time it takes to prepare the submission, and the level of support required during the process.