Comphya has received ISO 13485 certification for the design, development, manufacture and sterilization
28 October 2021
Lausanne, Switzerland, October 28th, 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.
CaverSTIM is the first implantable neurostimulator to restore erectile function, focused on non-responders to oral drugs. CaverSTIM is a neurostimulator with electrodes to be implanted in the pelvic cavity, which will activate and restore the neuronal path for penile erection. The technology consists of transmitting by radiofrequency operating instructions to the implantable unit, using an external control unit. The system includes two paddle leads with several electrodes each and connects to an Implanted Pulse Generator (IPG) to deliver electrical stimulation. The IPG, placed subcutaneously in the lower abdomen, is wirelessly programmed using a Clinician Programmer Application to enable the appropriate sets of electrodes and program the stimulation pulse sequence. The patient can turn stimulation on/off, adjust the amplitude, or select pre-defined stimulation pulse sequences using a Patient Remote Control. The IPG is periodically recharged using the external wireless Charger.
About Comphya SA
Comphya is a medical device company based in Lausanne, Switzerland, developing a novel implantable device to restore erectile function in patients non-responsive to oral drugs (e.g., Viagra), particularly spinal cord injury and post-prostatectomy patients. Today, these patients resort to intrapenial injections or penile implants, which are the only available yet painful, problematic and outdated therapies.
Comphya’s patented solution is based on neuroprosthetic principles and offers a unique and superior treatment for erectile dysfunction. The system stimulates the cavernosal nerve (pro-erectile nerve) via external wireless controllers, to restore natural penile erection. The company’s goal is to offer physiological sexual function and quality of life to large parts of the male population in great need.
Rodrigo Fraga-Silva, PhD
CEO & Co-founder