Press release
RE.DOCTOR LLC Achieves ISO 13485 Certification, Highlighting Commitment to Quality and Patient Safety in Medical Device Development
RE.DOCTOR LLC, a leading developer of innovative medical devices, today announced it has achieved ISO 13485:2016 certification. This internationally recognized standard signifies RE.DOCTOR's commitment to a robust quality management system (QMS) throughout the entire lifecycle of its medical devices, from conception and design to production, distribution, and servicing.ISO 13485 certification demonstrates RE.DOCTOR's dedication to:
Meeting regulatory requirements: The certification ensures RE.DOCTOR adheres to the highest quality standards set forth by regulatory bodies, facilitating market access for its medical devices globally.
Enhancing patient safety: A rigorous QMS prioritizes patient well-being by minimizing risks associated with medical device use.
Continual improvement: The standard fosters a culture of continuous improvement within RE.DOCTOR, ensuring its QMS remains effective and adaptable to evolving industry standards.
"Obtaining ISO 13485 certification is a significant milestone for RE.DOCTOR," said Simon Halliday, CEO of RE.DOCTOR LLC. "This achievement underscores our unwavering commitment to providing medical professionals with the highest quality, most reliable medical devices possible. Patient safety is paramount in everything we do, and this certification serves as a testament to that commitment."
Simon Halliday Comments on the Significance of ISO 13485 Certification
In a statement, Simon Halliday elaborated on the importance of ISO 13485 certification for RE.DOCTOR and the broader medical device industry:
Facilitating global market access: "This certification is a critical step in expanding our reach to new markets worldwide. By adhering to internationally recognized quality standards, we can ensure our devices meet the regulatory requirements of various countries, streamlining the market entry process."
Commitment to continuous improvement: "ISO 13485 is not a static achievement; it represents an ongoing commitment to excellence. The certification process requires us to maintain a culture of continuous improvement within our organization. This ensures our QMS remains effective in meeting the ever-evolving needs of the medical device industry."
RE.DOCTOR's Continued Dedication to Innovation and Quality
RE.DOCTOR's commitment to quality extends beyond ISO 13485 certification. The company fosters a culture of innovation, employing a team of highly skilled engineers and scientists dedicated to developing cutting-edge medical devices that address critical needs in the healthcare field.
The achievement of ISO 13485 certification signifies RE.DOCTOR's position as a frontrunner in the medical device industry. With a focus on quality, patient safety, and continuous improvement, RE.DOCTOR is well-positioned to deliver innovative medical devices that make a real difference in people's lives.
RE.DOCTOR LLC
1209 Mountain Road
Albuquerque, New Mexico, 87110
Phone: 307-278-9811
info@re.doctor
https://re.doctor
RE.DOCTOR LLC is a leading developer of innovative medical devices. The company is committed to developing high-quality, reliable devices that address critical needs in the healthcare field. RE.DOCTOR's team of engineers and scientists is dedicated to creating solutions that improve patient care and outcomes.
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