From AI-driven diagnostics to digital therapeutics and remote patient monitoring, our team guides you through every phase of the SaMD lifecycle – from concept, clinical evaluation, and risk management, through to technical development, regulatory approval, and post-market surveillance.
Whether you’re launching a Class I medical app or navigating MHRA, FDA, or CE mark approval for a higher-risk product, 6B delivers the technical, clinical, and regulatory expertise to bring your SaMD to market with confidence.
Understanding Software as a Medical Device
Software as a Medical Device (SaMD) refers to standalone software that performs a medical function without being part of a hardware medical device. This includes applications used for diagnosis, monitoring, prevention, treatment, or decision support — such as ECG interpretation tools, insulin dosing apps, or digital mental health interventions.
SaMD products are regulated under medical device legislation, including:
- UK MDR (MHRA)
- EU MDR (CE Mark)
- US FDA 21 CFR Part 820
- International standard ISO 13485
- Clinical safety standard DCB 0129 (UK NHS context)
SaMD must comply with stringent requirements for clinical evaluation, data protection, cybersecurity, and risk classification. The regulatory landscape continues to evolve alongside innovation, requiring a development approach that combines software engineering with regulatory foresight and clinical safety governance.
At 6B, we specialise in developing digital health products that meet these requirements without compromising on usability, performance, or innovation. We embed regulatory strategy from day one and work closely with you to design a pathway that supports both product vision and compliance outcomes.
Our SaMD Development Process
As a specialist Software as a Medical Device development company, 6B provides an end-to-end delivery model tailored to the unique demands of regulated healthtech. Our phased approach ensures each SaMD product is technically sound, clinically safe, and regulator-ready.
1. Discovery & Regulatory Pathway Planning
We begin with a structured discovery process to define your intended use, target user, and clinical claims. This allows us to determine the correct risk classification and regulatory pathway across the MHRA, EU MDR, and/or FDA frameworks.
We identify applicable standards (e.g. ISO 14971, IEC 62304, DCB 0129) and support you in building your Clinical Evaluation Plan, intended use statement, and early-stage risk assessment.
2. Design & Architecture
Our team designs your product with user needs, clinical safety, and regulatory alignment front of mind. We apply human-centred design principles and ensure that technical architecture supports cybersecurity, data privacy (including UK GDPR compliance), audit trails, and interoperability.
We also help define your software development life cycle (SDLC) documentation, validation plans, and traceability matrix, ensuring all regulatory documentation is captured early and accurately.
3. Agile Development & Verification
Using an agile delivery approach within a controlled quality management environment (ISO 13485 aligned), we develop your SaMD using secure, cloud-native technologies. Our developers follow IEC 62304-compliant practices, including unit testing, version control, and formal verification steps.
We integrate clinical safety case development and DCB 0129 hazard assessments throughout the build process.
4. Validation & Regulatory Submission Support
Once development is complete, we support rigorous verification and validation (V&V) testing – including functional testing, usability studies, performance benchmarking, and cybersecurity reviews.
We prepare you for regulatory submission by assembling Technical Documentation, Clinical Evaluation Reports, and support materials for CE Mark, UKCA, or FDA approval. We also collaborate with Notified Bodies, Clinical Safety Officers, and external QA teams as needed.
5. Go-Live & Post-Market Surveillance
6B supports deployment planning and provides hosting, monitoring, and incident response in line with your risk classification and regulatory obligations.
Post-market, we support updates, adverse event reporting, and continuous improvement processes to ensure long-term compliance and product safety.
Benefits of Working with a SaMD Development Company
Choosing a specialist Software as a Medical Device development company ensures your product is safe, effective, and built for successful regulatory approval.
Working with 6B gives you:
- End-to-end delivery from concept to post-market support
- Expert regulatory guidance across UK, EU, and US jurisdictions
- Compliance with ISO 13485, IEC 62304, ISO 14971, and DCB 0129
- Clinical safety case and risk management support
- Cybersecure, scalable software built for real-world healthcare use
- Faster route to market through mature delivery frameworks and reusable components
- Reduced compliance risk via documentation, traceability, and QMS alignment
Whether you’re building a digital biomarker, AI triage tool, or therapeutic app, 6B helps you deliver value to users and regulators alike.
Why Choose 6B for Software as a Medical Device Development?
6B combines deep experience in regulated software development with a proven track record in healthtech innovation. Our cross-functional team of developers, clinical advisors, product managers, and regulatory consultants work together to deliver safe, usable, and technically robust SaMD solutions.
We’ve delivered regulated digital products across Class I, IIa and IIb classifications — including decision support tools, diagnostic apps, and remote patient monitoring platforms. Our development approach integrates NHS clinical safety standards, international device regulations, and cloud-native technologies from the ground up.
With in-house expertise in:
- ISO 13485 QMS environments
- IEC 62304-compliant software development
- DCB 0129 safety case preparation
- Integration with NHS App, NHS Login, and GP systems
- UKCA/CE marking and FDA 510(k) pathways
We help digital health companies launch products that are safe, compliant, and commercially viable — and we work as a long-term partner to support evolution, maintenance, and ongoing compliance.
Speak To Our Software as a Medical Device Development Experts
Whether you're developing a new digital health product or extending an existing solution with Software as a Medical Device Development, 6B brings the technical expertise, healthcare insight, and experience needed to accelerate delivery.
