Regulatory and Compliance
Regulatory and Compliance at Forus Health: Building trust through regulatory excellence.
Our dedication to advancing healthcare innovation is matched by our meticulous focus on regulatory compliance and global standards. From concept to delivery, every product undergoes rigorous evaluation to ensure safety, efficacy, and quality. We take pride in our rigorous approach to regulatory and compliance processes, ensuring every product meets global state-of-the-art standards and deliver world class ophthalmic products and solutions.
Quality
Efficiency
Security
Navigating Complex Regulatory Landscapes
Healthtech is subjected to a diverse, complex, dynamic web of regulations across different regions and jurisdictions. Forus Health embraces the dynamic regulations worldwide to ensure our products and solutions meet the highest International standards. Our 20+ and counting global product and establishment certifications and registrations are a testament to our well defined Regulatory strategy and our expertise in navigating these complex global regulatory landscape.
Key Areas of Focus
Risk Assessment &
Regulatory Intelligence
Our process begins with a comprehensive risk assessment to identify potential regulatory challenges and develop mitigation strategies. We continuously monitor the global regulatory landscape, integrating real-time intelligence to stay aligned with compliance requirements.
Integrated Quality
Management System
Our Integrated Quality Management System (QMS) seamlessly incorporates global frameworks such as ISO 13485, 21 CFR 820, MDSAP, EU MDR, Indian Medical Device Rules, and Brazil’s ANVISA, among others. Embedded into daily operations, it ensures that every stage of the product life cycle meets diverse regulatory requirements while maintaining the highest standards of quality and compliance.
Evidence Based Validation
Through Bench and Clinical Testing
Our products undergo rigorous testing to meet the highest benchmarks for durability, reliability, and efficiency. This includes generating real-world evidence through clinical validation, stress and environmental testing, as well as transport and handling tests. Additionally, they are evaluated against global performance criteria set by various regulatory standards.
Data Protection and
Privacy
We comply with GDPR and HIPAA to safeguard patient data with transparent and secure practices. Additionally, we adhere to internationally recognized standards such as ISO 27001 for information security management, ISO 27017 for cloud security controls, and ISO 27018 for protecting personal data in cloud environments, strengthening our cybersecurity and privacy framework.
Global Product Certifications
and Approvals
With 20+ global certifications and approvals, we meet stringent international standards and lead the field with technology-backed innovations. Refer to each product for detailed regulatory information.
Continuous Monitoring
and Updates
Keeping up with evolving regulatory and QMS requirements requires continuous monitoring and evaluation. We adhere to strict internal and external audit systems to assess our practices and processes against established standards. Regular updates ensure our Quality Management System and products remain compliant with global regulations.
