Medical

BitWise applies its extensive embedded system experience, quality standards and project management skills to the demanding field of software development for medical instruments and systems. 

BitWise is certified to ISO13485:2003 and has over 10 years’ experience developing software projects to meet Food and Drug Administration (FDA) approvals for medical devices.  Our experience includes a variety of medical devices launched into all significant medical markets. 

Products range from hospital surgical systems to mobile patient devices.  We provide dedicated software consulting, development and testing expertise in support of a client's product roadmap. 

This is a key BitWise sector with services including:

  • Selection of platform and consultancy in design and risk management

  • Development of a concept or prototype into a validated and verified product

  • Design of a robust architecture for product evolution and roadmap

  • Full lifecycle of development for medical devices

  • Independent testing and instrumentation

  • Independent code review

  • Clinical data management and interfacing to devices, e.g. DICOM, HL7, telemedicine

  • Wireless integration and management of patient data and interfaces

case studyBitWise has been successfully audited by a range of customers and standards agencies including UL.