ISO 13485:2015 MD
If your operation specializes in producing innovative medical devices and diagnostic technologies, DataQuel is here to ensure you gain the certification you deserve. By following the internationally accepted standards of ISO 13485, we help our healthcare clients streamline production and maintain a competitive edge in the market.

What Is It?

As a measure of quality assurance, ISO 13485 is a globally recognized certification for diagnostic and therapeutic medical devices. The rigorous standards of this certification are designed to ensure patient confidence in such devices and reduce the likelihood of malfunctions.
How Can It Help Your Organization?
By earning this globally recognized certification, your operation can unlock more distribution opportunities and a clear path toward long-term growth. We proudly partner with leading certification consultants to guide our clients through the ISO 13485 process and help them achieve the recognition they deserve.

Economic Advantages

  • Streamlined quality assurance testing.
  • Fewer wasted resources for faulty processes.
  • Reduced barriers to global distribution.

Operational Advantages

  • Faster, more efficient workflows for quality management teams.
  • Scale-ready production processes.
  • Proven strategies for maintaining high-quality standards.

Legacy Advantages

  • Gold-star recognition from international certification entities.
  • Increased from patients and their providers.
  • Superior public image for your operation.

Get Certified With Us