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.
SaMD development is the process of designing, building, validating, and maintaining software that performs a medical function without being part of a hardware medical device. It includes regulatory planning, risk classification, IEC 62304 software lifecycle records, usability engineering, cybersecurity, clinical validation, and documentation for FDA or EU MDR review.
Custom SaMD DevelopmentFull-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.
SaMD Consulting
SaMD Architecture & Infrastructure
QMS, Compliance & Documentation
SaMD UX Design
Platform, IoT & Third-Party IntegrationsMedical device, EHR/EMR, telehealth, lab, wearable, FHIR, HL7, DICOM, and proprietary protocol integrations.
Insights into our team achievements and valued partnerships
97
%Net promoter score
200
+Professionals in the team
150
+Custom software solutions delivered
10
Years on the market
4.9
Client rating across platforms
Our SaMD consultants map your use case to the right classification and compliance strategy before you commit to architecture.
Binariks structures every SaMD engagement around the software, documentation, quality, and post-market evidence regulated teams need for review and launch.
Binariks delivers production-ready medical software built with verification, validation, and traceability in mind.
We prepare the core documentation package needed to support FDA, EU MDR, or internal regulatory review.
Binariks helps structure the quality and usability records expected for regulated SaMD products.
We help prepare the processes needed to keep SaMD compliant and maintainable after launch.
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.
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.
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.
We highly value their customer-first approach. If we have something going on, they’re easily available. Our clients are happy with their work.
The team at Binariks is vibrant, proactive, and efficient. Their autonomous nature complements their open approach.
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.
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.
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.
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.
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.
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.
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.
Their communication has been spot-on. They've been transparent about how much time they spend on each sprint as well.
Binariks brings real value to our business with their contributions, and their positive and "can-do" attitude.
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.
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.
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.
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.
We like Binariks' consulting. When we have an issue, Binariks always provides the right solution.
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.
Their communication skills are excellent. The project manager is particularly great to work with as he’s pushed me to communicate with them more.
We define intended use, users, product scope, risk class, and regulatory pathway.
Output: Intended-use statement, risk classification, pathway recommendation, compliance roadmap.
We design software architecture, hosting, security controls, data flows, and integrations.
Output: Architecture specification, data flow map, security baseline, integration plan.
We design and test workflows for clinicians, patients, or other target users.
Output: User flows, prototypes, usability protocol, formative testing plan.
We build in controlled iterations with traceability between requirements, risks, and tests.
Output: Working increments, verification records, test results, traceability matrix.
We validate the full system and prepare documentation for FDA or EU review.
Output: Validation report, technical file, submission package, reviewer-response support.
We support monitoring, updates, vigilance workflows, and controlled software changes.
Output: PMS plan, update process, monitoring setup, maintenance roadmap.
We define intended use, users, product scope, risk class, and regulatory pathway.
Output: Intended-use statement, risk classification, pathway recommendation, compliance roadmap.
We design software architecture, hosting, security controls, data flows, and integrations.
Output: Architecture specification, data flow map, security baseline, integration plan.
We design and test workflows for clinicians, patients, or other target users.
Output: User flows, prototypes, usability protocol, formative testing plan.
We build in controlled iterations with traceability between requirements, risks, and tests.
Output: Working increments, verification records, test results, traceability matrix.
We validate the full system and prepare documentation for FDA or EU review.
Output: Validation report, technical file, submission package, reviewer-response support.
We support monitoring, updates, vigilance workflows, and controlled software changes.
Output: PMS plan, update process, monitoring setup, maintenance roadmap.
Explore how Binariks helps healthcare and life sciences teams build secure, scalable, and workflow-ready digital products.
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SaMD development requires an engineering team that thinks in terms of regulatory frameworks, and Binariks fits that profile.
Binariks holds ISO 13485, ISO 27001, and ISO 9001 certifications for medical device quality, security, and quality management.
Binariks has a dedicated Healthcare Unit with 30+ professionals supporting SaMD, DTx, RPM, clinical decision support, and connected medical device projects.
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.
Engineers, QA specialists, BAs, and delivery teams work with regulatory documentation, software traceability, and validation needs in mind.
We choose technology based on product requirements, user roles, data sensitivity, integration needs, and long-term maintainability.
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.
Product decisions connected to intended use, risk class, and regulatory pathway
Architecture designed for security, interoperability, and lifecycle control
User experience shaped around clinical workflows and usability evidence
Development team that understands regulated healthcare software constraints
Post-launch support for updates, monitoring, and controlled product changes
Let???s align your product, architecture, QMS, and submission needs.
Ross Chornyy
Senior Vice President
Explore more ways to build secure, connected healthcare software with Binariks.??
Healthcare Software Development
Explore Service — Healthcare Software Development
Telemedicine Development
Explore Service — Telemedicine Development
Remote Patient Monitoring
Explore Service — Remote Patient Monitoring
EHR & EMR Development
Explore Service — EHR & EMR Development
Healthcare App Development
Explore Service — Healthcare App Development
HIPAA Compliance Consulting
Explore Service — HIPAA Compliance Consulting
Healthcare Digital Transformation
Explore Service — Healthcare Digital Transformation
Digital Therapeutics
Explore Service — Digital Therapeutics
Pharmaceutical Software Development
Explore Service — Pharmaceutical Software Development
Healthcare Cloud Services
Explore Service — Healthcare Cloud Services
Clinical Trial Software
Explore Service — Clinical Trial Software
Fitness Application Development
Explore Service — Fitness Application Development
Fitness Application Development
Explore Service — Fitness Application Development
Wearable Application Development
Explore Service — Wearable Application Development
Wellness App Development
Explore Service — Wellness App Development
Healthcare Software Testing
Explore Service — Healthcare Software TestingYes. Our SaMD consultants support the full regulatory lifecycle, from early classification and pathway selection through submission preparation and post-market compliance. For FDA, we cover 510(k), De Novo, and PMA pathways. For EU MDR, we support technical file compilation, Notified Body audit preparation, and MDCG guidance interpretation. We also assist with pre-submission meetings, Q-Sub requests, and FDA interaction strategy.
We design SaMD infrastructure in accordance with the FDA's 2023 cybersecurity pre-market guidance, ISO 27001, and relevant HIPAA/GDPR requirements. This includes threat modelling (STRIDE), secure software architecture documentation, encrypted data pipelines, audit-trail infrastructure, and access-control design. All architecture decisions are documented in a Software Architecture Document that becomes part of the regulatory technical file. We work on AWS GovCloud, Azure Health Data Services, and Google Cloud Healthcare API, depending on your compliance and data residency requirements.
Software as a Medical Device (SaMD) is software intended to perform a medical function — such as diagnosis, treatment, prevention, or monitoring of a medical condition — independently of any hardware device. Regular healthcare software (scheduling systems, billing tools, EHR viewers) performs administrative or operational functions and does not carry a medical intended purpose. The IMDRF definition is the reference point: if the software's output directly influences a clinical decision, it is likely SaMD and subject to medical device regulations, including FDA oversight or EU MDR.
The timeline depends primarily on risk classification and the intended submission pathway. A Class II 510(k) product with a clear predicate can take 12–18 months from architecture to cleared status. Class III PMA products typically require 24–36+ months given the clinical evidence requirements. EU MDR Class IIb/III products follow a similar extended timeline due to Notified Body review, an independent conformity assessment by an EU-designated organization. Early regulatory planning and a well-structured design history file are the most effective ways to compress these timelines. This is why we recommend engaging our SaMD consultants at project inception.
Yes. Our UX design practice follows the IEC 62366-1 usability engineering process — including user research, use specification development, formative usability evaluations, iterative design, and summative testing with the target user population. We produce the full Usability Engineering File (UEF) required for Class II and above FDA submissions and EU MDR technical documentation. Our designers work alongside regulatory affairs specialists so every UX decision is grounded in both clinical usability and compliance evidence requirements.
Binariks holds ISO 13485 certification — the international standard for quality management systems specific to medical devices. This is the foundation for all SaMD development engagements. For US-market products, we align QMS implementation with 21 CFR Part 820 (FDA Quality System Regulation / Quality Management System Regulation). We can also implement or audit client-side QMS structures using tools such as Greenlight Guru or Jama Connect, and support clients in preparing for ISO 13485 certification if they are establishing their own QMS for the first time.
Let's Start Your Project
We'd love to hear about the project you're working on. Simply complete the form and we'll be in touch.
What happens next?
Our expert will reach out to understand your goals and challenges
If needed, we'll sign an NDA to ensure full confidentiality
You'll receive a tailored roadmap with solution suggestions, timelines, and budget estimates
