DOFWARE provides end-to-end marking services of medical instrumentation and embedded software. Among the main typologies of services provided we cite:
- Safety Risk Analysis of medical instrumentation and the embedded software, according to ISO 14971 and IEC 62304;
- software adjustments according to Safety Risk Analysis results;
- design and application of integration, system, safety, security and validation tests on the medical instrumentation and the software embedded;
- set-up of the Technical File for compliance demonstration to the marking regulations (CE, UL (USA), CCC (China), GOST (Russia));
- Quality system program definition according to ISO 13485;
- support to Customer during marking trial performed by either a Notified Bodies (e.g. TUV, BSI) or the national healthcare authority (e.g. FDA).
The birth and growth “smart” electronic tools connected to the network have enabled us to provide cutting-edge of technology services, among which:
- Safety Risk Analysis about IT infrastructure malfunctionings;
- Security and Privacy Risk Analysis for what concerns sensible data (e.g. vulnerability analysis and intrusion test);
- “mobile health apps” validation tests for smartphones and tablets according to USA regulations about Mobile Medical Applications
Furthermore Customers are supported which need support for inspections made by Governative Agencies (e.g. Food & Drug Administration) and by Notified Bodies (e.g. TUV, BSI, IMQ).