Abu Dhabi, UAE: ProvenMed announces today that it has received the ISO 13485:2016 certification for Medical Device and Quality Management Systems for its innovative Med-Tech solutions.

“We are extremely proud of the work of our passionate team who completed the ISO 13485-2016 certification process, which recognizes that ProvenMed meets all the requirements to design and manufacture medical devices, said Amine Staali, Co-Founder & CEO at ProvenMed. This milestone is the perfect demonstration of ProvenMed’s expertise, agility and a testament to our commitment to safety and quality.”

ISO 13485:2016 is an internationally recognized standard of quality and safety for medical device industry. The management system standard ensures that an organization meets the regulatory requirements specific to the design, manufacture, and distribution of medical devices.

“Receiving the ISO 13485:2016 certification demonstrates the strategic commitment of our entire organization to quality, and to meeting customer’s and international regulatory expectations” Said Souheil Guessoum, Co-Founder at ProvenMed. “With total focus and a continuous commitment to quality, we are dedicated to expanding our quality system and regulatory acumen to meet market access requirements in the evolution of regulatory jurisdictions and to apply our competencies in the medical device sector”.

In 2020, ProvenMed has launched its innovative Med-Tech solutions including its flagship product ActivGo® for urinary incontinence management as a response to the growing aging population and need for safer and sustainable solutions. ActivGo® has since then been recognised as the most convenient alternative to the adult diapers and catheters that helps people regain control of their lives and be confident again.

About ProvenMed

ProvenMed is a medical device innovation company that is revolutionizing the urinary incontinence care industry with its patented solutions, ActivGo® for men and the Comfii™ system for women. These innovative solutions are the first urinary incontinence wearable devices of their kind, developed entirely from the patient's perspective. This approach ensures that they provide a comfortable, hygienic, and easy solution to help patients resume active lifestyles and regain confidence. ProvenMed is committed to innovating medical devices through compassionate empathy, empowering individuals, and improving their quality of life.

For more information, visit www.provenmed.com

Contact Data
ProvenMed PR team