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:

  1. ISO 13485 Certified
  2. US FDA 21 CFR Part 820 compliance
  3. Class II 510(k) cleared medical device
  4. CE Class IIa (MDD) Certified

For more information, please Contact Us By Email

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