ProvenMed gets ISO 13485:2016 certification for medical device design and manufacturing

ProvenMed has received the ISO 13485:2016 certification for Medical Device and Quality Management Systems for its innovative Med-Tech solutions.

ISO 13485:2016 is an internationally recognized standard of quality and safety for the 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.

On the record

"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."

"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."

The context

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.