de novo jury consulting
de novo jury consulting: Expert FDA Regulatory Strategy for De Novo, 510(k), and PMA Submissions
de novo jury consulting is a premier FDA regulatory consulting firm dedicated to guiding medical device innovators through complex regulatory pathways. Our expert team specializes in de novo classifications, 510(k) submissions, and Premarket Approval (PMA) strategies, ensuring a smooth and efficient journey from concept to market. We leverage deep industry knowledge and a proactive approach to help clients achieve regulatory success, particularly for In Vitro Diagnostics (IVD) and novel medical technologies. Partner with us to transform your regulatory challenges into market opportunities.
About
de novo jury consulting is a premier FDA regulatory consulting firm dedicated to guiding medical device innovators through complex regulatory pathways. Our expert team specializes in de novo classifications, 510(k) submissions, and Premarket Approval (PMA) strategies, ensuring a smooth and efficient journey from concept to market. We leverage deep industry knowledge and a proactive approach to help clients achieve regulatory success, particularly for In Vitro Diagnostics (IVD) and novel medical technologies. Partner with us to transform your regulatory challenges into market opportunities.
Additional information
### **Additional information**
- **Type:** firm
- **Company:** de novo jury consulting
- **Years of experience:** 7
- **510(k)s submitted (self-reported):** 12
- **Regions served:** US, EU
- **Client types:** startup, sme
- **Location:** US (Georgia)
- **Availability:** available_now
- **Certifications:** Regulatory Affairs Certified
### **Cruxi analysis**
- **Strength summary:** de novo Jury Consulting is a premier FDA regulatory consulting firm with deep expertise in guiding medical device innovators through complex regulatory pathways. With 7 years of experience, their team specializes in de novo classifications, 510(k) submissions, and Premarket Approval (PMA) strategies, having submitted 12 510(k) applications and handled 5 de novo applications. The firm's team has a strong background in In Vitro Diagnostics (IVD) and novel medical technologies, leveraging their knowledge to help clients achieve regulatory success. Their proactive approach and commitment to client success make them a valuable partner for medtech companies, particularly those seeking assistance with complex regulatory submissions. de novo Jury Consulting's regulatory expertise, FDA experience, and submission track record make them a top choice for medtech companies seeking to navigate the complex regulatory landscape.
- **Unique value:** de novo Jury Consulting's unique value lies in their deep understanding of the regulatory landscape and their ability to provide actionable insights that help medtech companies achieve regulatory success. With a strong combination of FDA experience, device expertise, and technical skills, the firm offers a unique differentiator in the market. Their proactive approach, commitment to client success, and expertise in complex regulatory submissions set them apart from other consulting firms, making them a valuable partner for medtech companies seeking to navigate the complex regulatory environment.
- **Ideal projects:** This firm is ideally suited for medtech companies involved in the development of IVD devices, novel medical technologies, or complex Class II or III medical devices requiring de novo or PMA submissions. Their team is well-equipped to support startups and small and medium-sized enterprises (SMEs) navigating the regulatory process for the first time or seeking to expand their product lines internationally. Companies looking to engage this firm should have a strong need for regulatory expertise, particularly in areas such as de novo classifications, 510(k) submissions, and PMA strategies. de novo Jury Consulting's expertise in these areas, combined with their technical competencies and FDA experience, make them an attractive partner for medtech companies seeking to overcome regulatory challenges.
- **Confidence score:** 90/100
- **Last analyzed:** Sat Dec 20 2025 01:42:24 GMT-0500 (Eastern Standard Time)
### **Qualifications & scope**
- **Submission types:** de-novo, 510k-traditional, 510k-special, pma, qms, international
- **Device classes:** class-ii, class-iii, class-i
- **Specialties:** ivd, regulatory strategy
- **Device panels:** ivd
- **Regulatory pathways:** 510k, de_novo, pma, post_market
- **Type:** firm
- **Company:** de novo jury consulting
- **Years of experience:** 7
- **510(k)s submitted (self-reported):** 12
- **Regions served:** US, EU
- **Client types:** startup, sme
- **Location:** US (Georgia)
- **Availability:** available_now
- **Certifications:** Regulatory Affairs Certified
### **Cruxi analysis**
- **Strength summary:** de novo Jury Consulting is a premier FDA regulatory consulting firm with deep expertise in guiding medical device innovators through complex regulatory pathways. With 7 years of experience, their team specializes in de novo classifications, 510(k) submissions, and Premarket Approval (PMA) strategies, having submitted 12 510(k) applications and handled 5 de novo applications. The firm's team has a strong background in In Vitro Diagnostics (IVD) and novel medical technologies, leveraging their knowledge to help clients achieve regulatory success. Their proactive approach and commitment to client success make them a valuable partner for medtech companies, particularly those seeking assistance with complex regulatory submissions. de novo Jury Consulting's regulatory expertise, FDA experience, and submission track record make them a top choice for medtech companies seeking to navigate the complex regulatory landscape.
- **Unique value:** de novo Jury Consulting's unique value lies in their deep understanding of the regulatory landscape and their ability to provide actionable insights that help medtech companies achieve regulatory success. With a strong combination of FDA experience, device expertise, and technical skills, the firm offers a unique differentiator in the market. Their proactive approach, commitment to client success, and expertise in complex regulatory submissions set them apart from other consulting firms, making them a valuable partner for medtech companies seeking to navigate the complex regulatory environment.
- **Ideal projects:** This firm is ideally suited for medtech companies involved in the development of IVD devices, novel medical technologies, or complex Class II or III medical devices requiring de novo or PMA submissions. Their team is well-equipped to support startups and small and medium-sized enterprises (SMEs) navigating the regulatory process for the first time or seeking to expand their product lines internationally. Companies looking to engage this firm should have a strong need for regulatory expertise, particularly in areas such as de novo classifications, 510(k) submissions, and PMA strategies. de novo Jury Consulting's expertise in these areas, combined with their technical competencies and FDA experience, make them an attractive partner for medtech companies seeking to overcome regulatory challenges.
- **Confidence score:** 90/100
- **Last analyzed:** Sat Dec 20 2025 01:42:24 GMT-0500 (Eastern Standard Time)
### **Qualifications & scope**
- **Submission types:** de-novo, 510k-traditional, 510k-special, pma, qms, international
- **Device classes:** class-ii, class-iii, class-i
- **Specialties:** ivd, regulatory strategy
- **Device panels:** ivd
- **Regulatory pathways:** 510k, de_novo, pma, post_market
Key Highlights
- de novo Jury Consulting is a premier FDA regulatory consulting firm with deep expertise in guiding medical device innovators through complex regulatory pathways. With 7 years of experience, their team specializes in de novo classifications, 510(k) submissions, and Premarket Approval (PMA) strategies, having submitted 12 510(k) applications and handled 5 de novo applications. The firm's team has a strong background in In Vitro Diagnostics (IVD) and novel medical technologies, leveraging their kno
- de novo Jury Consulting's unique value lies in their deep understanding of the regulatory landscape and their ability to provide actionable insights that help medtech companies achieve regulatory success. With a strong combination of FDA experience, device expertise, and technical skills, the firm offers a unique differentiator in the market. Their proactive approach, commitment to client success, and expertise in complex regulatory submissions set them apart from other consulting firms, making
Certifications & Trust Signals
- 7 years experience
- 12 510(k)s submitted (self-reported)
Buyer Snapshot
Best for
- This firm is ideally suited for medtech companies involved in the development of IVD devices, novel medical technologies, or complex Class II or III medical devices requiring de novo or PMA submissions. Their team is well-equipped to support startups and small and medium-sized enterprises (SMEs) navigating the regulatory process for the first time or seeking to expand their product lines internati
HQ:
US
Languages:
English
Status:
listed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
Regulatory Pathway Assessment, Device Classification Support, 510(k) Strategy & Authoring, 510(k) RTA Remediation / Refuse-to-Accept Fix, Predicate Research & Substantial Equivalence Strategy, De Novo Strategy & Authoring, PMA Strategy & Support, Pre-Sub / Q-Sub Preparation, FDA Meeting Support (Q-Sub / Type C)
Pathways Supported:
Traditional 510(k), Special 510(k), De Novo, PMA
Device Types Supported:
IVD, SaMD, Medical device
Supports Rta Remediation:
Yes
Supports Predicate Research:
Yes
Years Experience:
7
Num510k Submitted:
12
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
No
Device Panels:
ivd
Technology Types:
ivd_test, samd, ai_ml
Accepting New Clients:
Yes
