At Rekonnect, we are committed to upholding the highest standards of security, quality, and regulatory compliance for our B2B platform serving the medical device industry. To support this, we have prepared two summary reports that outline our approach to data protection, risk management, and software validation:
Software Validation Summary Report
Provides a summary of how the Rekonnect platform has been validated according to ISO 13485, ISO 14971, and ISO/TR 80002-2 standards. It confirms the platform's compliance with regulatory requirements and intended use across post-market processes and training management.
Contact [email protected] for a copy of the report.
Purpose
Validates that the Rekonnect B2B SaaS platform for medical device manufacturers meets its intended use and complies with standards such as ISO 13485 and ISO/TR 80002-2.Applicable Standards & Frameworks
ISO 13485 – Medical device quality management
ISO/TR 80002-2 – Risk management for medical device software
ISO 14971 – Medical device risk management
ISO/IEC 27001 – Information security controls
Scope of Validation
Covers all critical platform components:Document & record management
Post-market surveillance and feedback
Complaint handling and support
Training (digital & in-person)
Certification & user role management
Audit trails and compliance reporting
Validation Approach
Applied a risk-based V-model methodology
Requirements mapped to user needs and regulatory obligations
Validation covered IQ (Installation), OQ (Operational), and PQ (Performance) phases
Risks assessed per ISO 14971
Key Validation Activities
Created a Validation Master Plan (VMP)
Documented risk in a Risk Hazard Traceability Matrix (RHTM)
Executed test protocols for core platform functions
Managed deviations and controlled changes
Confirmed security controls per ISO/IEC 27001
Validation Outcome
All validation tasks successfully completed
No open deviations remaining
Compliance with intended use and regulatory standards confirmed
Risks mitigated to acceptable levels
Ongoing Maintenance
Platform maintained under change control and re-validation practices
Continuous monitoring of cybersecurity, data integrity, and performance
Supporting Documentation (under NDA)
Validation Master Plan
Requirements specifications
Risk Hazard Traceability Matrix
Test protocols and validation summary reports
Prepared & Approved
Prepared and signed by Rekonnect leadership in July 2025
Contact [email protected] for a copy of the report.