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Afferent receives ISO 13485 Accreditation, for its AffeX Hypertension Technology

Nikolai V Gourine

11 Dec 2023

Afferent Medical Solutions proudly announces its attainment of ISO 13485 certification from URS, underscoring the company's dedication to excellence and commitment to stringent quality standards. This achievement bolsters Afferent's position as a leader in developing advanced neuromodulation therapies for circulatory system diseases and other underserved therapeutic areas.

Afferent Medical Solutions, a pioneering UK-based bioelectronics medicine company specializing in innovative device-based neuromodulation solutions, proudly announces the attainment of ISO 13485 certification from URS, a trusted Notified Body. This accreditation stands as a significant testament to Afferent's unwavering dedication to excellence and its stringent adherence to rigorous quality standards under the careful stewardship of Afferent's Quality Manager, Michele Barker.


"This achievement underscores our relentless pursuit of quality and commitment to delivering safe and effective solutions to patients in need," stated Everard Mascarenhas, CEO at Afferent Medical Solutions. "Obtaining ISO 13485 accreditation is a pivotal milestone for us, reaffirming our dedication to upholding the highest standards of quality and regulatory compliance."


The ISO 13485 certification validates Afferent's capability to consistently design, develop and manufacture medical devices that meet customer and regulatory requirements. This milestone further solidifies Afferent's position as a leader in the development of advanced neuromodulation therapies for circulatory system diseases and other therapeutic areas underserved by existing medication.


For media inquiries or further information, please contact:

Nikolai V Gourine

info@afferentmedicalsolutions.com

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