SaMD Solutions Development & Consulting Services

Two things SaMD teams always need: a development partner who understands medical device regulations, and a regulatory partner who can actually ship software.

Binariks is both – delivering end-to-end SaMD solutions from architecture to market launch.

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Full-cycle software as a medical device (SaMD) development from clinical concept and architecture to market-ready product. We build high-quality software around real clinical needs. It does exactly what your users need and everything your regulators require.

Types of SaMD We Develop

Diagnostic aids and differential diagnosis tools

Treatment selection and care-planning support

Clinical risk stratification engines

Patient data analysis for medical recommendations

FDA Class II-III / MDR IIa-III

Why Clients Trust Us

Insights into our team achievements and valued partnerships

Net promoter score

200

Professionals in the team

150

Custom software solutions delivered

Years on the market

4.9

Client rating across platforms

Compliance Built Into Every Layer

United States – FDA

FDA SaMD guidance alignment

510(k), De Novo, and PMA pathway support

21 CFR Part 820 and Part 11 considerations

FDA cybersecurity guidance support

European Union – EU MDR

EU MDR 2017/745 technical documentation

MDCG guidance interpretation

CE marking support

IVDR considerations where applicable

International Standards

IEC 62304 software lifecycle records

ISO 14971 risk management

IEC 62366 usability engineering

ISO 13485 quality management alignment

Data Security & Privacy

HIPAA-aware architecture for US markets

GDPR-aligned data processing for EU markets

ISO 27001-based security controls

Encryption, audit trails, and access control

Not sure which regulatory pathway applies to your product?

Our SaMD consultants map your use case to the right classification and compliance strategy before you commit to architecture.

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Deliverables We Provide

Binariks structures every SaMD engagement around the software, documentation, quality, and post-market evidence regulated teams need for review and launch.

Validated SaMD Product

Binariks delivers production-ready medical software built with verification, validation, and traceability in mind.

Fully tested SaMD product ready for regulatory review
IEC 62304-aligned software development records
Verification and validation documentation
Requirement-to-test traceability support

Regulatory Technical Documentation

We prepare the core documentation package needed to support FDA, EU MDR, or internal regulatory review.

Design history file support
Risk management file aligned with ISO 14971
Software architecture document with data flows and interfaces
SOUP inventory and cybersecurity threat model

Quality and Usability Evidence

Binariks helps structure the quality and usability records expected for regulated SaMD products.

ISO 13485-aligned QMS documentation
SOPs, templates, and staff onboarding materials
Usability engineering file aligned with IEC 62366
Formative and summative usability study reports

Post-Market Readiness

We help prepare the processes needed to keep SaMD compliant and maintainable after launch.

Post-market surveillance plan
PMCF planning where applicable
Reporting cadence and escalation criteria
Controlled update and maintenance documentation

Trusted Clients

What our clients say about working with Binariks

Ioannis ChronakisCEO, Deontics

I'm impressed by the skill and enthusiasm of the people working on this project.
The primary measurable outcome is the successful delivery of components and assigned tasks for the completed phases of the project.

5.0

Steven ChristodoulopoulosSenior Director of eHealth Innovations & IT, Capsana

They have a lot of knowledge. We’ve built our data warehouse, and they have laid the foundation for our data analytics strategy. The solutions are performing as expected and meeting our business objectives.

5.0

Jake HalpertCEO, Healthcare Company

Binariks’ biggest strength is the quality of their people. We have a strong team leader who’s great at communicating with everybody and figuring things out quickly and smartly without getting too flustered or panicky. Overall, we have a great team structure with the right people and personalities.

5.0

Eugene BorukhovichCOO & Co-Founder, YourCoach Health

We highly value their customer-first approach. If we have something going on, they’re easily available. Our clients are happy with their work.

5.0

Takeshi SasakiFounder and CEO, Pivool Pte. Ltd.

The team at Binariks is vibrant, proactive, and efficient. Their autonomous nature complements their open approach.

5.0

Daniel CuendeCEO, CUENDE Infometrics

The attitude towards work is something Binariks takes pride in. It's a combination of a high-skilled team and quite mature management that makes this company stand out. They have a high level of responsibility and technical skills.

5.0

Amit PatankarCTO, BlueVoice Inc.

Binariks was capable of taking a design, providing adequate timelines and resources, scoping the project out, and delivering it. In my experience, most people can't deliver, but Binariks delivered.

5.0

XiaoChen GuoHead of Engineering, Planet of Finance

I appreciate how well they handle complaints. Developers don't always understand each other, and we're all working remotely. But Binariks has remained professional and humble. They always listen to what we want them to improve.

5.0

Tony LeeSenior QA Engineer, Modo Labs

I love the people I interact with at Binariks. [...] They're professional and down to earth, very easy to talk with. The QA resources I've worked with are very motivated and always want to get ahead of the game. If improvements are needed, they get done in a timely manner.

5.0

Russell HertzbergCTO, Briotix Health

Binariks' health technology expertise and their experience in building successful healthcare software solutions are their key differentiators. Additionally, they're extremely strong in having a complete, thorough, and high-quality architecture discovery phase.

5.0

John StruttonHead of Product Management, axitech

Binariks pays attention to the details. They take a high level of accountability and responsibility for tasks assigned to them. We can rely on them as part of our team rather than an external agency just putting in hours.

5.0

Michael MagdongonCEO & Co-Founder, Strabo

Binariks' clear communication is the best – they're consistent with it and with deliverables. They log their hours accurately, and if there's an issue, they respond in a timely manner. The team also sends meeting minutes after every management call, and their invoices come like clockwork.

5.0

Stuart FyfeManaging Director, Mothership Tech

Their communication has been spot-on. They've been transparent about how much time they spend on each sprint as well.

5.0

Dan EtheringtonHead of Software Development, Pelican Procurement

Binariks brings real value to our business with their contributions, and their positive and "can-do" attitude.

5.0

Gary LearnerCEO, Opus Digitas

They're agile and adaptable to change. They ask questions and don't make assumptions in order to understand your business and create the best possible solution. We've worked with lots of other partners, and they're one of the most organized and responsive.

5.0

Demian BigelowIntegrated Biometrics

What I really appreciate about Binariks is their mature technical expertise and high level of responsibility on given commitments: each expected increment was delivered as it was planned and just on time.

5.0

Sonya BeredimasVP Sales & Marketing, iVoyant

Their attitude towards their own work and their clients was impressive. They didn’t try to add unnecessary people to a project, it was a very lean and mature team.

5.0

Steve AnastasiCTO, EatStreet

They take a sense of ownership in these projects. Their team's focused and engaged in the work that they do. They're available all of the time and seem to be part of our team. Their team works well with our team's operation.

5.0

Damien JulienCreative Director, distylerie gmbh

We like Binariks' consulting. When we have an issue, Binariks always provides the right solution.

5.0

Victor CoutinFounder, Aire Fresco

They put a lot of emphasis on best practices for material design, quality user experience, and implementation. That’s going to be a key factor on customer retention.

5.0

Frederick CriminsFounder, Hamstoo

Their communication skills are excellent. The project manager is particularly great to work with as he’s pushed me to communicate with them more.

5.0

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Our SaMD Development Process

Step 01

Discovery & Regulatory Planning

We define intended use, users, product scope, risk class, and regulatory pathway.
Output: Intended-use statement, risk classification, pathway recommendation, compliance roadmap.

Step 02

Architecture & Infrastructure Design

We design software architecture, hosting, security controls, data flows, and integrations.
Output: Architecture specification, data flow map, security baseline, integration plan.

Step 03

UX Design & Usability Engineering

We design and test workflows for clinicians, patients, or other target users.
Output: User flows, prototypes, usability protocol, formative testing plan.

Step 04

Iterative Development & Verification

We build in controlled iterations with traceability between requirements, risks, and tests.
Output: Working increments, verification records, test results, traceability matrix.

Step 05

Validation & Regulatory Submission

We validate the full system and prepare documentation for FDA or EU review.
Output: Validation report, technical file, submission package, reviewer-response support.

Step 06

Post-Market Surveillance & Maintenance

We support monitoring, updates, vigilance workflows, and controlled software changes.
Output: PMS plan, update process, monitoring setup, maintenance roadmap.

Real-World Success Stories

Explore how Binariks helps healthcare and life sciences teams build secure, scalable, and workflow-ready digital products.

Healthcare

Data Science and AI/ML

ML Development

Custom Healthcare Development

SaMD

Leveraging ML and computer vision for real-time surgical scene recognition and enhancing operating room efficiency

Binariks helped the healthcare platform provider develop an AI-driven surgical video recognition solution

Explore how Binariks helped the client develop an AI-powered video recognition solution for surgical scene analysis. By using computer vision and machine learning, we enabled real-time tracking of key surgical events to improve OR efficiency, reduce downtime, and optimize scheduling. This innovative approach enhances hospital operations, streamlines workflows, and improves patient care.

View case study

Healthcare apps

HIPAA Compliance

Healthcare

Remote Patient Monitoring

Data Science and AI/ML

IoT

Mobile App Development

SaMD

Remote Patient Monitoring Application

A solution for remote monitoring for patients with Congenial Heart Disease

View case study

Healthcare

Quality Assurance

SaMD

Revolutionizing early heart disease detection

AI-powered cardiac screening platform

View case study

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Clients Across the Globe

SaMD development requires an engineering team that thinks in terms of regulatory frameworks, and Binariks fits that profile.

SaMD Delivery Built Around Regulatory Evidence

3 ISO Certifications

Binariks holds ISO 13485, ISO 27001, and ISO 9001 certifications for medical device quality, security, and quality management.

30+ Healthcare Specialists

Binariks has a dedicated Healthcare Unit with 30+ professionals supporting SaMD, DTx, RPM, clinical decision support, and connected medical device projects.

FDA & EU MDR Documentation Support

Binariks has hands-on experience preparing software documentation, technical file inputs, and audit-ready engineering evidence for FDA 510(k), EU MDR, and Notified Body review processes.

Regulatory Context in Delivery Teams

Engineers, QA specialists, BAs, and delivery teams work with regulatory documentation, software traceability, and validation needs in mind.

Tamila Karpa

Delivery Manager, Healthcare and Life Sciences Unit

SaMD projects slow down when evidence is collected after the product is built. The safer path is to make requirements, risks, tests, and usability decisions traceable from day one.

Technology Stack & Integrations

We choose technology based on product requirements, user roles, data sensitivity, integration needs, and long-term maintainability.

Cloud & Infrastructure

AWS

Azure Microsoft

Google Cloud

Kubernetes

Terraform

SaMD Software Built for Market Authorization

Building SaMD is not only about shipping functionality. Every product decision affects intended use, risk classification, usability, cybersecurity, validation, and future regulatory review. Binariks helps teams keep these layers connected throughout development, so the final product is easier to explain, verify, maintain, and evolve after launch.