28.10.2021 – Comphya announces that it has received the ISO 13485 certificate for Medical Device and Quality Management Systems.
The ISO 13485 is an internationally recognized quality standard. It specifies requirements for a quality management system where the organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. It verifies that a medical device manufacturer complies with the appropriate regulatory quality system requirements and it assumes that the manufacturer has the appropriate controls in place to ensure that the device developed and manufactured can be considered safe and effective.
“We are very pleased with obtaining the ISO 13485 certification and extremely proud of the work of our passionate team. This certification enables Comphya to achieve regulatory
compliance and, more importantly, patient safety for the upcoming clinical trials” stated Rodrigo Fraga-Silva, CEO and co-founder Mikael Sturny (CTO and co-founder) commented “The ISO 13485-2016 certification recognizes that Comphya meets all the requirements to design and manufacture medical devices, reflecting our aspiration for high quality”.
“The ISO 13485 certification demonstrate the commitment of our team to quality. It is a key milestone and substantial step forward for Comphya to deliver a safe and high-quality therapy
to the patients.” said Steve Swinson, Chairman of the Board This announcement is for informational purposes only.
Source: PR Comphya