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:
Security Commitment
Rekonnect is committed to protecting data confidentiality, integrity, and availability. An ISMS aligned with ISO/IEC 27001:2022 is already in place. Certification audit is targeted for Q1 2026.
Contact [email protected] for a copy of the report.
Key Security Practices
Information Security Governance: ISMS formally governs security, backed by senior leadership.
Risk Management: Documented process to assess and mitigate risks using ISO standards.
Access Control: Role-based access and secure authentication are enforced.
Data Protection: GDPR-compliant handling of personal and healthcare data.
Business Continuity: Continuity and incident plans ensure resilience.
Supplier Security: Security standards applied to third-party providers to mitigate supply chain risks.
Standards and Frameworks
ISO/IEC 27001:2022 – Information Security Management
ISO/TR 80002-2 – Risk management for medical device software
ISO 14971 – Medical device risk management
GDPR – European data protection regulation
Certification Progress
ISMS is operational across core functions
Security controls documented in a Statement of Applicability (SoA)
Internal audits and reviews completed
Certification audit planned for early 2026
Documentation (Available Upon NDA)
ISMS Manual
Information Security Policy
Risk Management Process
Statement of Applicability
Platform validation documentation
Governance
The document was prepared and approved by company leadership in July 2025.
Contact [email protected] for a copy of the report.