What services does Adaptive Biotechnologies Corporation offer?

Adaptive Biotechnologies Corporation offers Regulatory Pathway Assessment, 510(k) Submission Authoring, De Novo & PMA Strategy, QMS Setup & Implementation and other FDA regulatory consulting services for medical device companies.

What regulatory pathways does Adaptive Biotechnologies Corporation specialize in?

Adaptive Biotechnologies Corporation specializes in 510k, De Novo, Pma and other FDA regulatory pathways for medical devices.

What is Adaptive Biotechnologies Corporation's regulatory experience?

Adaptive Biotechnologies Corporation has 7+ years of experience, 10+ 510(k) submissions in FDA regulatory affairs.

Adaptive Biotechnologies Corporation

Principal Consultant, Regulatory Affairs

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 spe...

Experience: 7+ years

Submissions: 10 510(k)

Expertise & Specializations

Regulatory Pathways

510kDe NovoPmaIdeQ Sub

Device Specialties

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Regions Served

Adaptive Biotechnologies Corporation provides regulatory consulting services to clients in:

United States (FDA)European Union (MDR/IVDR)Canada (Health Canada)Asia-PacificLatin AmericaMiddle East & Africa

Credentials & Recognition

Professional Experience

Former Big MedTech RA Leader
Enterprise experience

Executive Summary

Professional Overview

Core Specializations

Regulatory Pathways

510kDe NovoPmaIdeQ Sub

Device Specialties

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Services Offered

Regulatory Pathway Assessment
Strategic assessment to determine the appropriate FDA regulatory pathway (510(k), De Novo, PMA) for your medical device.

510(k) Authoring & Submission
Complete 510(k) submission preparation, documentation authoring, and FDA submission management.

De Novo & PMA Strategy
Strategic planning and support for De Novo and PMA pathways, including clinical trial design and FDA meeting preparation.

QMS Setup & Implementation
Quality management system design, implementation, and validation to meet FDA and ISO requirements.

Post-Market Support
Post-market surveillance, adverse event reporting, and ongoing regulatory compliance support.

Cruxi Independent Snapshot

Best suited for

• MedTech companies seeking expert regulatory guidance

Experience signals

Regions: US, EU, CA, APAC, LATAM, MEA
Background: 7+ years of regulatory experience.

Cruxi view

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.

This analysis is generated by Cruxi AI using public information and may not capture the full scope of the consultant's experience.

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