At Abby Health, we are committed to providing the highest standards in health screening and medical device safety. We are proud to announce that we are now ISO 13485 accredited, reinforcing our position as a trusted partner for occupational health, employee wellness, and insurance companies.
But what exactly is ISO 13485, and why is it important for your organisation?
What is ISO 13485?
ISO 13485 is the internationally recognised quality management system (QMS) standard for medical devices. It ensures that medical technology companies meet strict regulatory requirements for design, development, production, and servicing. This accreditation demonstrates compliance with global best practices in medical device safety, reliability, and data integrity.
Why ISO 13485 Matters for Occupational Health & Safety
For companies focused on occupational health and safety (OHS), having a reliable and compliant health screening solution is crucial. Abby Health’s ISO 13485 accreditation ensures that:
Health screening stations meet stringent safety and performance standards.
Employees receive accurate and secure health assessments, reducing risks and improving workplace well-being.
Organisations can confidently integrate Abby Health into their OHS programs, ensuring compliance with local and international health regulations.
Enhancing Employee Wellness with Certified Health Screening Solutions
Employee wellness is a growing priority for businesses aiming to improve workforce productivity and reduce absenteeism. With ISO 13485 certification, Abby Health:
Delivers precise health data, enabling companies to make informed decisions about wellness programs.
Reduces manual workload for wellness teams, allowing seamless health tracking and intervention.
Supports early detection of health risks, empowering employees to take proactive steps in improving their well-being.
A Game-Changer for Insurance Companies
For insurance providers, accurate health screening data is critical for risk assessment, policy pricing, and customer engagement. ISO 13485 accreditation means that Abby Health offers:
Regulatory-compliant health screening technology, ensuring insurers receive reliable data for underwriting.
Seamless integration with wellness initiatives, helping insurers engage with policyholders proactively.
A trusted, globally recognised health screening partner, ensuring adherence to the highest industry standards.
Why ISO 13485 Strengthens Trust in Abby Health
In addition to ISO 13485, Abby Health is also accredited by SAHPRA, FDA, and CE, making our health screening solutions among the most trusted and compliant in the industry. For businesses focused on occupational health, employee wellness, and insurance, this means:
Confidence in data accuracy and device reliability.
Compliance with global and local healthcare regulations.
Improved efficiency in health and wellness programs.
Take the Next Step
If you’re looking to enhance occupational health & safety, employee wellness, or insurance-based health initiatives, now is the time to partner with an ISO 13485-certified provider. Let’s discuss how Abby Health can support your organisation—get in touch today!
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