Medovex Corporation Receives ISO 13485:2016 Certification
Certification Confirms Company’s Quality Management System Continues to Adhere to Stringent Requirements for the Consistent Design, Development, Production and Delivery of Medical Devices
ATLANTA, Sept. 25, 2018 (GLOBE NEWSWIRE) -- Medovex Corp. (OTCQB:MDVX) ("Medovex" or the "Company"), the developer of the DenerveX® System, a new and novel device designed for enduring relief of Facet Joint Syndrome related to chronic back pain, a non-addictive, non-opioid drug alternative capable of restoring a patient to a more normal and active lifestyle, today announced that it has received ISO 13485:2016 certification, an internationally recognized quality standard specific to the medical device industry.
This certification confirms the company’s quality management system adheres to stringent requirements for the consistent design, development, production and delivery of medical devices. Certification to the 2016 version is required by March 2019 in order to meet the European CE mark approval requirements and to ensure uninterrupted product availability to our growing international customer base.
Jill Schweiger, Medovex’s Senior VP Regulatory, Clinical and Quality stated, “We are proud of this accomplishment in meeting the new ISO 13485: 2016 requirements well ahead of the deadline. This certification is evidence of our team’s ongoing commitment to make quality our top priority. With this certification, customers can be confident that Medovex is dedicated to maintaining the highest level of quality, efficiency and responsiveness required by the medical community.”
ISO certification is an internationally recognized quality standard for medical devices that is awarded when an organization demonstrates its ability to provide medical devices and related services that consistently meet customer and regulatory requirements applicable to medical devices and related services, and is a requirement for medical device clearance in Canada, the EU and a majority of other countries that require products meet EU safety, health and environmental and regulatory requirements. During the last year, the Company focused its efforts on updating its quality management system to meet the new revised ISO 13485 requirements.
Medovex was formed to acquire and develop a diversified portfolio of potentially ground breaking medical technology products. Criteria for selection include those products with potential for significant improvement in the quality of patient care combined with cost effectiveness. The Company's first pipeline product, the DenerveX System, is intended to provide long lasting relief from pain associated with facet joint syndrome. To learn more about Medovex Corp., visit www.medovex.com.
Safe Harbor Statement
Certain statements in this press release constitute "forward-looking statements" within the meaning of the federal securities laws. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "project," "plan," "intend" or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including without limitation those set forth in the Company's filings with the Securities and Exchange Commission (the "SEC"), not limited to Risk Factors relating to its business contained therein. Thus, actual results could be materially different. The Company expressly disclaims any obligation to update or alter statements whether as a result of new information, future events or otherwise, except as required by law.
Source: Medovex Corp.