July 20, 2012 — Integrity Life Sciences announced that TÜV SÜD Product Service GmbH of Munich, Germany, issued to Integrity the CE Marking (Certificate of European Conformity) and compliance with these requirements is proved within a certified quality management system according to EN ISO 13485 (International Standards Organization).
Integrity Life Sciences was granted by TUV SUD the CE Mark together with an ISO 13485 certificate representing a certified quality management system in compliance with the International Organization of Standardization’s standard 13485:2003 / AC:2009. Together, the CE Mark and the ISO Certification serve as a virtual passport to the world as it is recognized beyond the stringent borders of Europe.
This follows the European Union’s “New Approach Directives” and is mandatory for all manufacturers. This legislation requires Integrity to clearly display CE Marking on its products and ensures legal responsibility that the Integrity Spinal Care System Medical Device conforms to the requirements of the directive and for applying CE Marking.
The letters “CE” are a well known accomplishment to most in the international medical community. Established by the EU, the term initially identified with the phrase “EC Mark” and it was officially replaced by “CE Marking” in the 1993 Directive 93/68/EEC. Today, the letters “CE” are the abbreviation of French phrase “Conformité Européene” which literally means “European Conformity.” “CE Marking” is now used in all EU official documents.
CE Marking on Integrity’s products means that, as a manufacturer, Integrity is declaring that their product complies with the essential requirements of the relevant European health, safety, and environmental protection legislation in accordance with the “Product Directives.” Product Directives contain the “essential requirements” and/or “performance levels” and “Harmonized Standards” to which Integrity’s products must conform.
Harmonized Standards are the technical specifications (European Standards or Harmonization Documents), which are established by several European standards agencies, the European Committee for Standardization and the European Committee for Electro-technical Standardization.
When Integrity Life Sciences places the CE Marking on its Integrity Spinal Care System, it is affirming to governmental officials that the product has been legally cleared to be placed on the market in their country. James Gibson, president and CEO of Integrity Life Sciences, fully understands the duties and responsibilities associated with obtaining and maintaining the CE Mark certification.
He says, “We have now repeatedly demonstrated to the most stringent standards the world knows that our products are safe and achieve their intended use.” He went on to explain the ongoing commitment required to maintain his organization’s reputation.
“Now the hard work continues because with the successful award of the CE Mark, it permits the ongoing inspection of our facilities and the withdrawal of any non-conforming products by customs and enforcement vigilance authorities should Integrity ever fall short of its quality assurance record.”
The term ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems.
As a result, it includes some particular requirements for medical devices and the manufacturers, such as Integrity Life Sciences. The ISO 13485:2003+AC:2009 (Medical Devices) accreditation certifies Integrity for the design, development and manufacturing of their Integrity Spinal Care System and confirms Integrity’s compliance with this demanding quality standard.
Gibson stated, “At Integrity, we know that we must meet and exceed our customer’s requirements. As a provider of medical products associated with the treatment of debilitating spinal disorders, and our recognized expertise in the medical device industry, we must not only meet the stringent regulatory requirements applicable to medical devices and their related services, because our name is Integrity, we must exceed them as well.”
Gibson concluded with the following thoughts, “Today, every medical device manufacturer strives to separate themselves from their perceived competitors. With the CE Mark and ISO Certification it opens the entire world as our marketplace.” Mr. Gibson was also referencing the company’s previous success, the FDA 510(k) clearance that was issued from the US FDA’s, Division of Surgical, Orthopedic and Restorative Devices, Office of Device Evaluation, Center for Devices and Radiological Health. “The cumulative impact on Integrity as an organization is not only these prestigious certifications but when implemented properly into an organization, they can be strategic tools that reduce costs by minimizing waste and errors, while increasing productivity, quality and safety. In the end, Integrity wins and so does the doctor who uses our equipment with confidence, and especially the patient who will be receiving the treatments.”
Source: Integrity Life Sciences, IntegrityLifeSciences.com