Adaptive Biotechnologies Corporation
Expert FDA Regulatory Consulting for Medtech: 510k, De Novo, PMA
Adaptive Biotechnologies Corporation is a premier regulatory consulting firm dedicated to guiding medtech companies through the complexities of FDA submissions, including 510k, de novo, and premarket approval (PMA). With a seasoned team possessing extensive expertise in regulatory affairs and strategic planning, we have a proven history of ensuring compliance and accelerating market entry. Our specialized knowledge encompasses a wide range of medical device classes and areas, including IVD, molecular diagnostics, hematology, oncology, and infectious disease diagnostics. We provide a full spectrum of services, from initial pathway and classification assessments to predicate analysis, test strategy development, and comprehensive 510k authoring.
About
Adaptive Biotechnologies Corporation is a premier regulatory consulting firm dedicated to guiding medtech companies through the complexities of FDA submissions, including 510k, de novo, and premarket approval (PMA). With a seasoned team possessing extensive expertise in regulatory affairs and strategic planning, we have a proven history of ensuring compliance and accelerating market entry. Our specialized knowledge encompasses a wide range of medical device classes and areas, including IVD, molecular diagnostics, hematology, oncology, and infectious disease diagnostics. We provide a full spectrum of services, from initial pathway and classification assessments to predicate analysis, test strategy development, and comprehensive 510k authoring.
Additional information
### **Additional information**
- **Type:** firm
- **Company:** Adaptive Biotechnologies Corporation
- **Years of experience:** 7
- **510(k)s submitted (self-reported):** 10
- **Ex-Big MedTech:** Yes
- **Regions served:** US, EU, CA, APAC, LATAM, MEA
- **Client types:** large_medtech, academic
- **Location:** United States
- **Availability:** available_now
### **Cruxi analysis**
- **Strength summary:** Adaptive Biotechnologies Corporation stands out as a highly valuable consulting firm for medtech companies, boasting an impressive array of regulatory expertise and experience. Their team has extensive experience in regulatory affairs, strategic planning, and submissions to the FDA, with a proven track record of success in medtech, including 10 successful 510k submissions. The firm's expertise spans various medical device classes, including IVD, molecular diagnostics, hematology, oncology diagnostics, and infectious disease diagnostics. Adaptive Biotechnologies Corporation's comprehensive range of services, from pathway assessment and classification assessment to predicate analysis, test strategy development, and full 510k authoring, makes them an ideal partner for medtech companies seeking top-notch regulatory consulting. Their ability to navigate the complex regulatory landscape and ensure compliance and timely market entry sets them apart from other consulting firms.
- **Unique value:** Adaptive Biotechnologies Corporation's unique value lies in their ability to combine deep regulatory expertise with a proven track record of success in medtech, making them an indispensable partner for companies seeking to navigate the complex regulatory landscape. Their team's extensive experience in regulatory affairs, strategic planning, and submissions to the FDA, coupled with their comprehensive range of services, sets them apart from other consulting firms and makes them a trusted advisor for medtech companies.
- **Ideal projects:** The perfect project for Adaptive Biotechnologies Corporation would involve regulatory strategy and submissions for IVD devices, particularly those utilizing molecular technology, for a large medtech company. This would allow the firm to leverage their expertise in IVD, molecular diagnostics, and regulatory affairs to guide the client through the complex regulatory process and achieve successful market entry. With their comprehensive range of services and proven track record of success, they are well-suited to support clients in navigating the medtech regulatory landscape. This project would be a good fit for companies looking to enter the market with IVD devices, as Adaptive Biotechnologies Corporation's expertise would be highly valuable in ensuring compliance and timely market entry.
- **Confidence score:** 90/100
- **Last analyzed:** Sat Dec 20 2025 01:44:38 GMT-0500 (Eastern Standard Time)
### **Qualifications & scope**
- **Submission types:** 510k-traditional, de-novo, pma
- **Device classes:** class-i, class-ii, class-iii
- **Specialties:** ivd, hematology, cardiovascular, orthopedic, neurology, radiology, dental, regulatory strategy, risk management, quality management systems
- **Device panels:** ivd
- **Regulatory pathways:** 510k, de_novo, pma, ide, q_sub, hde, post_market, pre-submission
- **Type:** firm
- **Company:** Adaptive Biotechnologies Corporation
- **Years of experience:** 7
- **510(k)s submitted (self-reported):** 10
- **Ex-Big MedTech:** Yes
- **Regions served:** US, EU, CA, APAC, LATAM, MEA
- **Client types:** large_medtech, academic
- **Location:** United States
- **Availability:** available_now
### **Cruxi analysis**
- **Strength summary:** Adaptive Biotechnologies Corporation stands out as a highly valuable consulting firm for medtech companies, boasting an impressive array of regulatory expertise and experience. Their team has extensive experience in regulatory affairs, strategic planning, and submissions to the FDA, with a proven track record of success in medtech, including 10 successful 510k submissions. The firm's expertise spans various medical device classes, including IVD, molecular diagnostics, hematology, oncology diagnostics, and infectious disease diagnostics. Adaptive Biotechnologies Corporation's comprehensive range of services, from pathway assessment and classification assessment to predicate analysis, test strategy development, and full 510k authoring, makes them an ideal partner for medtech companies seeking top-notch regulatory consulting. Their ability to navigate the complex regulatory landscape and ensure compliance and timely market entry sets them apart from other consulting firms.
- **Unique value:** Adaptive Biotechnologies Corporation's unique value lies in their ability to combine deep regulatory expertise with a proven track record of success in medtech, making them an indispensable partner for companies seeking to navigate the complex regulatory landscape. Their team's extensive experience in regulatory affairs, strategic planning, and submissions to the FDA, coupled with their comprehensive range of services, sets them apart from other consulting firms and makes them a trusted advisor for medtech companies.
- **Ideal projects:** The perfect project for Adaptive Biotechnologies Corporation would involve regulatory strategy and submissions for IVD devices, particularly those utilizing molecular technology, for a large medtech company. This would allow the firm to leverage their expertise in IVD, molecular diagnostics, and regulatory affairs to guide the client through the complex regulatory process and achieve successful market entry. With their comprehensive range of services and proven track record of success, they are well-suited to support clients in navigating the medtech regulatory landscape. This project would be a good fit for companies looking to enter the market with IVD devices, as Adaptive Biotechnologies Corporation's expertise would be highly valuable in ensuring compliance and timely market entry.
- **Confidence score:** 90/100
- **Last analyzed:** Sat Dec 20 2025 01:44:38 GMT-0500 (Eastern Standard Time)
### **Qualifications & scope**
- **Submission types:** 510k-traditional, de-novo, pma
- **Device classes:** class-i, class-ii, class-iii
- **Specialties:** ivd, hematology, cardiovascular, orthopedic, neurology, radiology, dental, regulatory strategy, risk management, quality management systems
- **Device panels:** ivd
- **Regulatory pathways:** 510k, de_novo, pma, ide, q_sub, hde, post_market, pre-submission
Key Highlights
- Adaptive Biotechnologies Corporation stands out as a highly valuable consulting firm for medtech companies, boasting an impressive array of regulatory expertise and experience. Their team has extensive experience in regulatory affairs, strategic planning, and submissions to the FDA, with a proven track record of success in medtech, including 10 successful 510k submissions. The firm's expertise spans various medical device classes, including IVD, molecular diagnostics, hematology, oncology diagno
- Adaptive Biotechnologies Corporation's unique value lies in their ability to combine deep regulatory expertise with a proven track record of success in medtech, making them an indispensable partner for companies seeking to navigate the complex regulatory landscape. Their team's extensive experience in regulatory affairs, strategic planning, and submissions to the FDA, coupled with their comprehensive range of services, sets them apart from other consulting firms and makes them a trusted advisor
Certifications & Trust Signals
- 7 years experience
- 10 510(k)s submitted (self-reported)
Buyer Snapshot
Best for
- The perfect project for Adaptive Biotechnologies Corporation would involve regulatory strategy and submissions for IVD devices, particularly those utilizing molecular technology, for a large medtech company. This would allow the firm to leverage their expertise in IVD, molecular diagnostics, and regulatory affairs to guide the client through the complex regulatory process and achieve successful ma
HQ:
United States
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), De Novo, PMA, Pre-Sub / Q-Sub
Device Types Supported:
IVD, Medical device
Supports Rta Remediation:
Yes
Supports Predicate Research:
Yes
Years Experience:
7
Num510k Submitted:
10
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
Yes
Device Panels:
ivd
Technology Types:
ivd_test
Accepting New Clients:
Yes
