RE.DOCTOR LLC Achieves ISO 13485 Certification, Underscoring Commitment to Quality and Patient Safety in Medical Device Development

Albuquerque, NM, March 12, 2024 — RE.DOCTOR LLC, a leading developer of innovative medical devices, today announced it has achieved ISO 13485 certification. This internationally recognized standard signifies the company’s commitment to a robust quality management system (QMS) for the design, development, production, and sale of medical devices.

The ISO 13485 certification process involves a rigorous assessment of an organization’s QMS. By achieving this certification, RE.DOCTOR demonstrates its dedication to:

Meeting regulatory requirements: The QMS ensures compliance with relevant medical device regulations, including those set forth by the European Union (EU) MDR and the U.S. Food and Drug Administration (FDA).

Patient safety: The focus of the QMS is on prioritizing patient safety throughout the entire medical device lifecycle.

Risk management: A proactive approach to identifying and mitigating potential risks associated with medical devices is a core principle of the QMS.

Process improvement: The QMS is designed to continuously improve the effectiveness of RE.DOCTOR’s processes.

“We are incredibly proud to receive ISO 13485 certification,” said Simon Halliday, CEO of RE.DOCTOR LLC. “This achievement reflects our unwavering commitment to developing and delivering the highest quality medical devices that improve patient outcomes. The rigorous standards of ISO 13458 provide a strong foundation for our ongoing dedication to patient safety and innovation.”