Era Yönetim Test Ve Belgelendirme Hizmetleri A.Ş. has giving certification, training and test services for medical device manufacturers under European product Conformity.

ERA BIOMEDICAL TEST LABORATUARY established in 2014 to perform biomechanical tests for orthopedic implants. Biomechanical tests are performing convenient with updated standards ASTM & ISO.   Our Laboratory is growing its test capacity with the new technology to respond to the sector’s needs.  For necessary situations, literature research conducts for orthopedic implants. Static tests, compressive tests, dynamic fatigue and torsion tests are performed by the qualified engineers. Abrasion test will start soon.

Era Yönetim Test Ve Belgelendirme Hizmetleri A.Ş. has accredited to the EN ISO/IEC 17021 standard  in 2012 and had offered TS EN ISO 9001:2008 and TS EN ISO 13485:2012 management systems provided certification services until July, 2016. By the strategic decisions made by the board of directors, the accreditation was not renewed and management systems certification was aborted.

• Provide the necessary resources to conduct all test activities in a transparent manner based on the principles of independence, impartiality, honesty and confidentiality with its competent personnel.
• Takes full responsibility for the accreditation and testing services it carries out within the framework of its competencies.
• The personnel employed in the test services shall provide services that are reliable, free from any commercial, financial and other pressure, based on objective data and that prevent the risks arising from the fact that the personnel performing the reporting of the test results are significantly familiar or trusting the customer.
• It belongs to all real and legal persons operating in the private sector and public sector where testing and reporting services are provided; All information, data and documents obtained during the services provided cannot be given to any third party or published in public channels for any purpose without the written permission of the right holder, except for the part requested by the authorized institution (s) and accreditation institution (s). If there is no legal obstacle in the event of disclosure of confidential information of the customer due to legal obligations or contractual commitments in the test procedures, the customer or the person concerned shall be informed. The confidentiality of the information, data and documents belonging to the real and legal persons served by ERA Management Test and Certification Services A.Ş. It is the responsibility of its top management and this confidentiality is fully respected.
• Ensuring protection of confidential information and property rights obtained from test reports provided to individuals / organizations.
• ERA Management Test and Certification Services Inc. does not, take any action to reduce confidence in its integrity, impartiality, decision-making or honesty of its work. In order to ensure full compliance with the principles of impartiality and independence, it analyzes potential conflicts of interest and takes the necessary measures to ensure that personnel involved in testing activities are not assigned to certification services in accordance with national and international standards and legislation requirements for their accreditation and competence. When a risk to impartiality arises, it is evaluated by the relevant unit manager and carries out the necessary activities to eliminate or minimize the risk.
• Any behaviors that may harm the reputation of the service persons / organizations will be avoided provided that they adhere to the ERA Management Biomechanical Test Laboratory documents established within the framework of national and international standards and legislation requirements based on accreditation and authorizations.
• The independence of the personnel assigned within the scope of the test services from the real and legal persons who provide test and reporting services and the impartiality of their activities are undertaken by the senior management of the company. All the conditions required for all personnel to carry out their activities within the limits of professionalism and in technical and professional competence commensurate with the activity they perform, are subject to ERA Management Test and Certification Services Inc. Provided by and provided.