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Software As A Medical Device Development

Software as a Medical Device (SaMD) development is a service offered by 6B. We are Software as a Medical Device development specialists offering Software as a Medical Device specification creation, Software as a Medical Device development and testing, Software as a Medical Device integration with a medical device, and more.

With many years of healthcare IT experience backed up by 6B’s expertise in creating secure software for medical devices and SaMD you are in safe hands working with 6B on your Software as a Medical Device development project.

Medical Device Software Development

Two key steps in medical device software development is planning for IEC 62304 compliance and finally validating and verifying IEC 62304 compliance.

Planning – through medical device software development planning we focus on documenting intended use, classification, medical device regulatory strategy and product requirements.

Validation and verification –  following ISO 29119 and ISTQB best practices for quality assurance 6B designs and implements tests to validate and verify your medical device software to ensure IEC 62304 compliance.

IEC 62304 Compliant Software Development

6B develops software and apps that meet IEC 62304 compliance requirements. We ensure your software is developed inline with its intended use and is compliant with ISO 13485, ISO 14971, and IEC 62304 standards.

6B are an IEC 62304 software development partner experienced in developing IEC 62304 compliant software including software for medical devices and Software as a Medical Device (SaMD).

Our medical device bespoke software development services comprise consultation, specification creation, software development and testing, integration with a medical device, and more.

With many years of healthcare IT experience, 6B are your partner for compliant medical device software development.

Software for medical devices and SaMD

6B can help with both software for medical devices development and Software as a Medical Device (SaMD) development.

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

Software as a Medical Device (SaMD) – we can develop software, mobile apps, web development and more 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
  • 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 and security are key priorities for medical software development. To ensure your medical device software is secure and compliant 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 (SaMD) development can be complex – 6B are here to help to ensure the process is efficient. We have:

  • 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 via HL7 FHIR
  • 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

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