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).
