Regulatory Certification - Why it is so Important

Orthocrat is committed to maintaining the highest quality standards for all its products. This goal is fully achieved through the efforts made by the company to comply with the most stringent international standards. Orthocrat not only meets all regulatory requirements for medical products but also guarantees to our customers that we really care about - and are responsible for - the quality, safety and performance of all our products. In the past Orthocrat received FDA clearance (510K Number K073714) for the distribution and sales of TraumaCad in the United States. Orthocrat recently received several additional international certifications within the scope of compliance to international standards. Orthocrat obtained these certifications after a thorough review process, including an on-site inspection, by Kema Quality B.V., one of the most highly respected European Notified Bodies specializing in testing and certification of medical devices. Quality performed an impartial testing assessment and certification process that led to Orthocrat's receipt of both ISO 13485:2003 and the CE approvals.

• ISO 13485:2003 – An international standard designed to provide medical device companies with a common approach to applying quality management parameters. It specifically requires that companies develop and implement a quality management system for the design, development and production of medical devices. In order to obtain ISO certification, Orthocrat was required to establish a quality control system based on a “process approach” to ensure its ability to provide medical devices that consistently meet customer and regulatory requirements.
• ISO13485:2003 CMDCAS – The motivation for ISO certification was – as described above – to formalize the quality system already established in Orthocrat. In addition, the process facilitated access to additional markets such as to Canadian medical facilities. Orthocrat is pleased to be certified for the Canadian market as well.
• Medical Device Directive 93/42/EEC – CE certification is used by the European Competent Authorities (National Ministries of Health) as a way to ensure that a company’s products have met all of the requirements set out in European Directives related to medical devices. It basically deals with permission to market and put into service medical devices. Traumacad, Orthocrat’s preoperative planning tool, fully complies with these requirements and proudly bears the CE mark.

Working with a Notified Body

Before a manufacturer can affix the CE marking which permits free circulation of products throughout the European Community, a medical device must comply with the requirements of the relevant EU Directives, and in particular to essential requirements on health and safety. The organization that determines whether the appropriate conformity assessment procedures have been followed is known as a Notified Body. Where a Notified Body is involved in the CE marking the CE mark is accompanied by the Notified Body's identification number. A Notified Body is a certification organization which the national Ministries of Health designate to carry out one or more of the conformity assessment procedures described in the annexes of the Directives. Typical activities that can be undertaken by a Notified Body include, Quality Assurance Review, Examination of the Design, Type Examination, Verification, and Production and Product Quality Assurance. Please note that several of these processes are not applicable for Orthocrat products.