Software for Medical Devices: Design, Development & MDR/IVDR Compliance
Build, upgrade, and maintain CE-ready medical device software with an ISO 13485–certified software development company. We deliver compliant, secure, connected solutions aligned with MDR/IVDR, IEC 62304, ISO 14971, cybersecurity and usability requirements.
Why medical device companies choose us
As a full lifecycle medtech partner and critical supplier under MDR, we develop medical device software that is compliant from the start and prevents costly code rewrites or MDR and IVDR delays. You get embedded, mobile, web, desktop and cloud solutions built right first time with compliance engineered into every stage by our engineering and regulatory teams, ensuring smooth CE approval, reduced audit risk and a product that is safe, connected and ready for the market.
Key areas we support
Mobile apps for medical devices (including companion apps)
Connectivity for medical devices
Software in a medical device (SiMD)
Firmware development
Software and documentation transition from MDD to MDR (or IVDR)
Cost efficient maintenance with remote monitoring
Post Market Surveillance and CAPA Support
We support legal manufacturers across the full software lifecycle. Explore each area to see how we deliver compliant software solutions.
Our services for medical device software
We deliver end-to-end, certification-ready software and documentation, built from day one to minimise costly rework and avoid certification delays. Our integrated engineering and regulatory approach ensures your project is designed, developed and documented in one compliant flow, with documentation created alongside development rather than after it, across the entire lifecycle from architecture to post market activities.
Mobile app design and development
Connected health ecosystems engineering
MDD to MDR software and documentation transition (or IVDR)
Remote monitoring and diagnostics for medical devices
Regulatory-compliant support and maintenance, including PMS, CAPA and lifecycle documentation updates.
Mobile app design and development
We design and develop mobile software that enables medical device companies to deliver new functionality through standalone applications or companion apps connected to medical hardware, that extend device capabilities, simplify user operation and support more cost-efficient device designs by moving complexity from hardware to software.
Our team delivers native iOS and Android applications with secure BLE, WiFi or cloud communication, engineered under MDR and IVDR expectations and aligned with ISO 13485, IEC 62304, IEC 62366, ISO 14971, GDPR and HIPAA.
Connected health ecosystems engineering
We build connected health solutions that securely link medical devices, mobile apps, cloud platforms and clinical systems into one coherent ecosystem.”
This includes IoMT-enabled architectures, HIS integration, HL7 FHIR data exchange, secure cloud architectures and compliance aligned interoperability engineering to ensure safe communication and MDR and IVDR ready documentation.
MDD to MDR software and documentation transition (or IVDR)
We support manufacturers in transitioning legacy MDD or IVDD software to MDR or IVDR without costly delays, unnecessary rewrites or certification risks.
Our team performs gap analysis, code and documentation remediation, refactoring and verification to align your software with MDR and IVDR requirements, creating updated documentation as part of the development flow rather than after it, while preparing your technical file for CE.
Remote monitoring and diagnostics for medical devices
We develop remote monitoring and diagnostics capabilities that reduce maintenance costs, extend the reach of service operations and provide technicians with on-site diagnostic tools for faster and more effective issue resolution.
This includes cloud connectivity, sensor integration, secure data pipelines and AI assisted diagnostics engineered in line with highest expectations for safe device performance.
Regulatory-compliant support and maintenance, including PMS, CAPA and lifecycle documentation updates.
We support manufacturers in post-market software activities by providing structured maintenance, support and development services that keep medical device software stable, compliant and ready for ongoing market use.
Our scope includes software maintenance and SLA-based support, incident and trend analysis, SOUP tracking, documentation updates and agreed inputs for PMS and CAPA, supporting continuous product improvement after market release.
Case studies
See how medical device manufacturers use our end to end, compliant software development services in real projects.
About Revolve Healthcare
A regulatory first software development partner for medical devices.
Our integrated process supports full design control, verification and traceability expected by legal manufacturers and notified bodies.
We operate within an ISO 13485 certified QMS and use our Scrum 62304 framework aligning Agile delivery with IEC 62304, ISO 14971 and IEC 62366.
We have contributed to more than ten MDR or IVDR aligned software initiatives ranging from new development to code refactoring and documentation remediation.
Schedule a consultation with our engineering and regulatory specialists
During the session we can:
review your software challenges,
discuss MDR or IVDR expectations,
outline the best technical and compliance approach,
answer questions about documentation.
The consultation takes around 45 minutes and does not require any commitment.