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Hire Dedicated FDA SaMD Engineers in the USA

When a software feature meets the FDA’s definition of a Software-as-a-Medical-Device (SaMD), the engineering bar changes overnight. Design controls under 21 CFR Part 820, software lifecycle under IEC 62304, risk management under ISO 14971, and a 510(k) or De Novo pathway submission stop being optional. Most software engineers, even experienced healthcare engineers, have never shipped under these constraints.

Taction Software’s FDA SaMD engineers have shipped against Class II SaMD pathways, including 510(k) submissions, predicate analyses, and design history file (DHF) production. Engagements start at $8,000 per engineer per month with a 14-day onboarding window and a Business Associate Agreement signed before any PHI touches our systems. For productized regulatory pathway work, see our FDA SaMD Pathway add-on at $60K over 8 weeks.

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Trusted Partners

Trusted by Industry Leaders Worldwide

Industries and Use Cases We Have Delivered

MedTech — Class II SaMD pathways for imaging, monitoring, and decision support

Digital health — first FDA clearance for clinical decision support and triage AI

Pharma companion software — software paired with drug therapies

Hospital-built AI — internal AI features that crossed the SaMD threshold

Recognition

Awards & Recognitions

Why FDA SaMD Engineering Is a Distinct Discipline

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What We Screen For Before Placement

Production SaMD shipping experience — at least one 510(k)-cleared or De Novo product
Design controls fluency — DHF production and audit experience
IEC 62304 lifecycle deliverable production
Risk management under ISO 14971

What a Taction FDA SaMD Engineer Does on Day One

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Week One and Two Deliverables

Classify your feature against the SaMD framework and risk categorization
Identify the regulatory pathway (510(k), De Novo, or PMA)
Begin predicate analysis if 510(k)
Stand up the design history file (DHF) structure
Map your engineering workflow against design control requirements
Identify the cybersecurity and Part 11 implications

Technologies and Frameworks Our SaMD Engineers Work With

Regulatory Frameworks

21 CFR Part 820 (Quality System Regulation)
21 CFR Part 11 (Electronic Records and Signatures)
IEC 62304 (Software Life Cycle Processes)
ISO 14971 (Risk Management)
IEC 82304-1 (Health Software General Requirements)
FDA Section 524B (Cybersecurity)
FDA Predetermined Change Control Plan (PCCP) for AI/ML

Lifecycle Deliverables We Produce

Design History File (DHF)
Device Master Record (DMR)
Risk Management File
Software Requirements Specification (SRS)
Software Architecture Document (SAD)
Software Verification and Validation (V&V) protocols
Predicate analysis and substantial equivalence documentation
Cybersecurity premarket submission package

AI-Specific SaMD Patterns

AI/ML PCCP for continuously learning algorithms
Locked-vs-adaptive algorithm decisions
Algorithm-change protocol design
Real-world performance monitoring tied to FDA reporting

For background, read our FDA SaMD compliance guide, FDA SaMD for clinical AI, and our work on the FDA 510(k) pathway for AI imaging tools.

Engagement Models and Pricing for FDA SaMD Engineers

Dedicated FDA SaMD Engineer

$8,000 per engineer per month with a 3-month minimum.

SaMD Pod

$24,000 to $60,000 per month for a pod including engineers, regulatory specialists, and quality professionals.

Productized SaMD Pathway

Our FDA SaMD Pathway add-on at $60K over 8 weeks productizes the regulatory groundwork — classification, predicate analysis, DHF skeleton, and submission strategy.

For estimates, use the healthcare AI cost calculator.

HIPAA Compliance Baseline

BAA executed before any access to PHI-bearing systems

HIPAA Security Rule controls in addition to FDA requirements

21 CFR Part 11 electronic records and signatures validated

Audit logging that satisfies both HIPAA §164.312(b) and Part 11

When to Hire an FDA SaMD Engineer (and When Not To)

Use a Dedicated FDA SaMD Engineer When

Your software feature has crossed or may cross the SaMD threshold
You are preparing a 510(k) or De Novo submission
You are an established medical device company adding software features
You are a digital health startup pursuing FDA clearance for the first time
You are adding AI/ML to an existing cleared device and need a PCCP

Choose a Different Engagement When

You are not sure whether SaMD applies — start with the FDA SaMD Pathway add-on for classification
You need general healthcare AI engineering — hire healthcare AI engineers
You need MLOps for cleared devices — hire healthcare MLOps engineers

The 14-Day Process

Start the 14-Day Engineer Match

FAQs

Frequently Asked Questions About Hiring FDA SaMD Engineers

$8,000 per engineer per month with a 3-month minimum. For productized pathway work, the FDA SaMD Pathway add-on is $60K over 8 weeks.

14 days from discovery to engineer-on-team.

Yes. We have shipped 510(k)-cleared products and produced predicate analyses, design history files, and submission packages.

Yes. Predetermined Change Control Plans for AI/ML SaMD are part of our practice — see our FDA SaMD for clinical AI guide.

Yes. Class A, B, and C software lifecycle deliverables are part of the screening.

A healthcare AI engineer builds AI features in HIPAA-covered environments. An FDA SaMD engineer adds the regulatory-pathway disciplines required when the feature is a medical device. Many projects need both.

Yes. Every engagement begins with a BAA.