Verification & Validation

Overview

BioT is an OTS (off-the-shelf) platform module that is used as part of a medical device system by integrating to other components of the system (e.g. device hardware or other software components).
BioT software development is fully compliant to IEC/EN 62304 and FDA guidance. It is validated and compliant to the regulatory requirements for all software classifications. BioT as a company is certified with ISO 13485 – Quality Management system – requirements for regulatory purposes.
The BioT platform has been validated across multiple clinical domains, clinical settings and intended uses. Among the domains validated: Cardiovascular, Dermatology, Neurology, Orthopedic, Respiratory, Gynecology, Sleep disorder, Wound care, and Obstetrics. Among the clinical settings validated: Home, Clinic, Continuum of Care. Among the intended uses validated: Diagnostic, Monitoring, Therapeutic, including for class III devices.

BioT’s Design History File

As part of the product, BioT delivers a complete IEC 62304 Design History File (DHF) conforming to both FDA and MDR requirements for any class of software, including class C. The BioT DHF is composed of the following documents:
• SDLCP - Software Development Life Cycle Procedure
• RM/RA - Risk Management and Analysis
• SRS + SRR – Software requirement specification + Review
• SDD + SDR - Software detailed design + Review
• STP + STD - Software test plan +description
• TRR - Test readiness review
• STR - Software test report
• OTS - Off-The-Shelf Software Validation Report
• Full Traceability file (Risk, SRS, SDD, STD)
• SVD - Software Version Description
• Production deployment checklist
• HIPAA and GDPR Checklist
• Cybersecurity Report
• SBOM - Software Bill of Materials

Upon request, additional documents such as unit test reports and penetration test reports are also available.

Usage of the BioT DHF

The documentation of BioT is stand-alone documentation which can be integrated, or referenced by the device documentation, or expanded (by adding the device additional requirements/risks/design and testing).