Reflexonic Achieves FDA Clearance, CE Marking, And ISO 13485:2003 Certification In Less Than A Year
06/25/2012

Medical technology developer expands market for Viberect ED device with support from Emergo Group

Online PR News – 25-June-2012 – Chambersburg/PA – Reflexonic, LLC, the Chambersburg, Penn.-based medical device manufacturer that developed the Viberect non-pharmaceutical device for treatment of erectile dysfunction (ED), has achieved ISO 13485:2003 quality system certification and CE Marking in order to commercialize its product in the European Union.

We were able to establish our ISO 13485 compliance and go through the CE Marking process with minimal complications by relying on Emergo Group’s expertise.

The Viberect device targets men with mild to moderate ED symptoms, those undergoing post-prostatectomy erectile rehabilitation as well as those with spinal cord injuries causing ejaculatory dysfunction. Viberect™ functions via high-frequency and amplitude vibratory stimulation of penile nerves in order to activate sexual pathways leading to successful erection and ejaculation.

With support from Austin, Tex.-based medical device regulatory and quality assurance consultancy Emergo Group, Reflexonic has now implemented an ISO 13485-compliant quality management system required by European regulators, and has begun marketing Viberect in European territories. (The firm obtained US FDA 510(k) clearance to sell Viberect in the US six months ago, also with Emergo Group assistance.). Since FDA clearance, there are several multicenter clinical trials underway for treatment of ED and spinal cord injury ejaculatory treatment using the Viberect showing high satisfaction and success, and pending publication. Canada, Australia, and Brazil licensing is pending. The Viberect is already licensed to sell in India, the Middle East, and most of Southeast Asia.

“Viberect is now the only therapeutic hand-held device for treatment of ED cleared for sale both in the US and EU,” says Dr. Kambiz Tajkarimi, Reflexonic Founder and President. “We were able to establish our ISO 13485 compliance and go through the CE Marking process with minimal complications by relying on Emergo Group’s expertise.”

“Interest in noninvasive, physiological and non-pharmaceutical ED treatments such as Viberect will no doubt rise as more patients become aware of these treatments,” says Julie Powell, Vice President of Quality Assurance at Emergo Group. “Leveraging Emergo Group’s support for ISO 13485 and CE Marking certification allowed Reflexonic to expand its presence from the US to Europe in less than a year.”

Stuart Goldman, Senior Consultant at Emergo Group, adds, “Taking on an ISO 13485 implementation plus CE Mark certification on your own can be prohibitively expensive and complicated for all but the largest medical device companies. By partnering with Emergo Group, Reflexonic now has access to the two largest medical device markets in the world.”

About Reflexonic, LLC
Reflexonic is an urologist-owned and operated US medical device company dedicated to creating simple, intelligent, and physiological hand-held devices that millions of men can use to restore and preserve their sexual and urinary health. Further information can be found at www.reflexonic.com

For additional information, please contact:
Reflexonic, LLC
Dr. Kambiz Tajkarimi, Founder and President
202-321-8162

About Emergo Group
Emergo Group is a global medical device consulting firm providing a wide range of services for device registration, QMS compliance, clinical trial management, in-country representation, reimbursement and distributor search consulting. Further details at www.emergogroup.com

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