Certificates
Quality Assurance
We develop, manufacture and market bone density assessment solutions that have a direct and positive impact on the lives of countless patients around the world.
We hold ourselves to the highest standards of quality in everything we do. We deliver customer-focused quality, take personal responsibility for quality and monitor and continually improve our Quality Management System.
Quality and Regulatory Compliance
With 20 years of medical device experience, we have developed a thorough understanding of the complex regulatory environment. Every product is manufactured to exact specification, in full compliance with applicable regulatory requirements.
Our certifications and registrations include:
- ISO 13485 Certified
- US FDA 21 CFR Part 820 compliance
- Class II 510(k) cleared medical device
- CE Class IIa (MDD) Certified
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