Software As A Medical Device Development Company UK

Our software as a medical device development services comprise consultation, specification creation, UI/UX design, software development and testing, assurance and compliance, integration with a medical device, and more.

With many years of healthcare IT experience, 6B is your partner for compliant medical device software development across any software as a medical device classification (Class I, IIa, IIb, or III).

Software for medical devices and SaMD

6B can help with both software for medical devices development and software as a medical device development.

Software for medical devices – we can develop safe and MHRA-compliant software for medical equipment for Physicians, Nurses, Surgeons, Lab assistants and more.

Software as a Medical Device (SaMD) – we can develop solutions to assist patients and healthcare specialists across a variety of use cases including treatment planning, medical image viewing, monitoring and observations, medication administration and more.

Medical device software development approach

6B offers ‘full service’ medical device software development services, typically our process includes the following key stages:

Discovery – during discovery and alpha we work closely with your team to document requirements and understand feasibility, constraints and opportunities.
Design – we design user-centric UI and UX to ensure we achieve intuitive, modern and visually stunning interfaces.
Development – we develop the functionality defined in discovery and design, ensuring strict IEC 62304 compliance, MDR compliance, and MHRA compliance.
Quality assurance – through established QA processes we ensure your medical device software is secure and compliant.
Launch – we help to navigate governance and compliance through to live deployments of your medical device software.
Ongoing support – Following launch we can work with you to an agreed SLA to support your medical device software.

Medical software Quality Assurance

We understand quality assurance, IEC 62304 compliance, as well asn MDR and MHRA compliance, and security are key priorities for medical software development.

To ensure your medical device software is secure and compliant, inline with our established ISO 27001 processes and policies, we apply OWASP’s S-SDLC (Secure Software Development Life Cycle) practices that involve comprehensive and multi-level quality assurance.

Our established QA processes and practices ensure: high-quality architecture and code; intuitive and high-quality user experience; proactive automated monitoring and detection of exceptions; medical software product validation according to ISO 13485/IEC 62304.

Why choose 6B for Software As A Medical Device development?

Developing software for medical devices and software as a medical device development can be complex – 6B are here to help to ensure the process is efficient. We have:

Compliance with software as a medical device (SaMD) standards and regulations, including: regulatory frameworks (MDR and MHRA), device classifications (Class I, IIa, IIb, or III), risk management, quality management systems (ISO 13485), software development compliance (IEC 62304), data protection (GDPR, ISO 27001), interoperability (e.g., HL7, DICOM, etc), NHS standards including NHS DTAC, NHS DSPT, NHS DCB0129, NHS DCB0160.
Many years of healthcare IT experience developing solutions for physicians, surgeons, nurses, patients for both public and private sector organisations.
Experience integrating to many third-party healthcare applications including leading EHRs, EPRs, PAS, etc via HL7 FHIR, HL7 V2/V3, and more.
ISO 27001 certification ensuring we follow strict security and compliance processes
Knowledge of healthcare standards (HL7, CPT, XDS/XDS-I, etc).
Pre-built modules for medical device software development to accelerate your project roadmap.

Software as a Medical Device Interoperability and Integration Expertise

Interoperability for most software as a medical device development is paramount. At 6B, we specialise in developing software as a medical device that seamlessly integrates with a wide array of healthcare systems and devices.

Our expertise in interoperability ensures that your software can communicate effectively with electronic health records (EHRs), Electronic Patient Records (EPR), medical imaging systems, laboratory information systems, and other critical healthcare infrastructure. Utilising industry standards such as HL7 FHIR, SNOMED CT, DICOM, and more, we ensure that data flows smoothly and securely across different platforms, enhancing clinical workflows and patient care.

Our software as a medical device integration solutions are designed to be scalable and adaptable, supporting the dynamic needs of healthcare environments. Whether it’s integrating with existing hospital systems or ensuring compatibility with future technological advancements, 6B’s approach ensures that your software as a medical device can operate efficiently within diverse healthcare ecosystems.

Post-Launch Software as a Medical Device Surveillance and Continuous Improvement

Post-launch we recognise that post-market surveillance is critical to maintaining the safety and efficacy of medical software. Our post-launch services ensure that your software remains compliant with regulatory standards and continues to meet user needs.

We carry out robust monitoring systems to track the performance of your software as a medical device in real-world settings, capturing valuable data on user interactions, system functionality, and any potential adverse events. This data-driven approach enables us to promptly address any issues, implement necessary updates, and continuously improve the software.

We also integrate user feedback and clinical data, and we ensure that your software as a medical device evolves in response to emerging healthcare trends and technological advancements, ultimately enhancing patient outcomes and user satisfaction. Our proactive approach to post-market surveillance not only helps in maintaining regulatory compliance but also fosters innovation, ensuring that your software as a medical device remains at the forefront of medical technology.

Software as a Medical Device development specialists

We are passionate about developing compliant, robust, secure, and clinically safe Software as a Medical Device.

We’re keen to partner with digital health innovators to support Software as a Medical Device development projects – contact us if you are ready to get started.

What are the key regulatory standards when developing software as a medical device?

All software development for medical devices needs to comply with various regulatory standards, including the Medical Device Regulation (MDR), Medicines and Healthcare products Regulatory Agency (MHRA) guidelines, and IEC 62304 for software lifecycle processes. Additionally, adherence to ISO 13485 for quality management systems and ISO 27001 for information security management are essential.

How does 6B handle the interoperability and integration of software as a medical device with existing healthcare systems?

6B specialises in ensuring that software as a medical device seamlessly integrates with a wide array of healthcare systems. We use industry standards such as HL7 FHIR, SNOMED CT, and DICOM to ensure smooth and secure data flow across different platforms, enhancing clinical workflows and patient care. Our integration solutions are designed to be scalable and adaptable, supporting both current and future healthcare technology needs.

How does 6B ensure the security and quality as a software as a medical device development company?

6B employs comprehensive quality assurance processes that adhere to IEC 62304 and ISO 13485 standards. Our ISO 27001 certification ensures rigorous security measures are in place, and we integrate OWASP’s Secure Software Development Life Cycle (S-SDLC) practices to ensure multi-level quality assurance, covering high-quality architecture and code, proactive monitoring, and medical software validation.

What post-launch services does 6B offer for software as a medical device?

Post-launch, we provide robust support, maintenance, and monitoring to track the performance of your software as a medical device in real-world settings. This includes capturing data on user interactions, system functionality, and any adverse events. We use this data to address issues promptly, implement necessary updates, and continuously improve the software. We also incorporate user feedback and clinical data to ensure the software evolves with emerging healthcare trends and technological advancements, maintaining regulatory compliance and enhancing patient outcomes.

How does 6B handle risk management as a software as a medical device development company?

Risk management is integral to our software as a medical device development process. We follow the ISO 14971 standard for risk management of medical devices, which involves identifying, evaluating, and mitigating risks throughout the software lifecycle. Our process includes continuous risk assessment during development, stringent testing to identify potential issues, and implementing risk control measures to ensure the safety and efficacy of the medical device software.

Software as a Medical Device Insights

Considerations when developing Software as a Medical Device

In this post we look at the UK’s regulatory environment, influenced by both local and international standards, and how to ensure Software as a Medical Device compliance and market success.

Understanding what classifies Software as a Medical Device in England

In England, software as a medical device is subject to various regulations to ensure safety and efficacy, governed primarily by the Medicines and Healthcare products Regulatory Agency (MHRA). This post aims to clarify what classifies software as a medical device and the different classes of these devices.

Our Digital Health services

When it comes to healthcare, our skilled multi-disciplined team have successfully delivered projects for clients in the public and private sectors, ranging from complex system integrations to legacy system overhauls and everything in between.

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