Documentation
Our Product Hub was designed to provide a comprehensive overview of the Joyhann portfolio of products . With product overviews,visual imagery, features and benefits, product spec information, and an array of support content, we are here to support you.
Certified Quality and Regulatory Assurance
Our centralized repository provides definitive validation of global compliance and operational integrity. The Declaration of Conformity
(DoC) formally attests adherence to applicable directives (e.g., EU MDR, IVDR), specifying harmonized standards fulfilled for regulatory compliance.
Certificates deliver authenticated proof of accredited quality management systems (ISO 13485) and region-specific regulatory
approvals (e.g., CE Mark, UKCA), demonstrating conformity to international frameworks.
Test Reports present transparent evidence of device safety and performance, including electromagnetic compatibility (EMC) validation, biocompatibility testing (ISO 10993), and environmental resilience per IEC 60601 protocols.
The Risk Management File documents comprehensive hazard analysis aligned with ISO 14971, detailing risk control measures, mitigation
efficacy, and post-market surveillance requirements.
All materials undergo rigorous version control and are maintained in audit-ready formats, enabling stakeholders to verify end-to-end
regulatory integrity across the product lifecycle
Compliance Documentation
