You will be able to pass certification to various standards. Your customers will accept the certificate and for them it will guarantee that you comply with the requirements of ISO 13485. Certificates are issued after the audits in accordance with international accreditation rules, which is reflected in the issued ISO 13485 Certificate. Nobody can just buy an ISO 13485 certificate. Each client is assigned a personal manager who will work with you both during the preparation and conduct of audits, and at other times.
ISO 13485 is the internationally recognized. You will know who to contact with your ISO certification question. Regulatory requirements are increasing at every step of a products life cycle and public scrutiny is intensifying. Contact us and get the opportunity to optimize your costs We always try to suggest reasonable and a competitive price of ISO 13485 certification.
The FDA played its part in the revision of ISO 13485:2016, because it is more convenient for industries to develop a Quality Management System if the needs of different countries are same. Numerous countries depend on ISO 13485:2016 in regulating medical devices. Our policy of working with an auditor provides our clients from Russia, Belarus, Kazakhstan and other countries with additional value from the audit due to the competence of auditors. The FDA’s Quality System Regulation Part 820 is aligned with ISO 13485:2016 to a greater extent than ISO 9001:2015. AJA EUROPE auditors meet the highest competency requirements. ICAlps is the first European independent ASIC design house with a Quality Management System (QMS) certified according to ISO 13485, ISO 9001, EN 9100.
Our auditors are professional and are near you. dumas-01758804 N° dordre : ANNÉE 2016 THÈSE DEXERCICE / UNIVERSITÉ DE RENNES 1 sous le sceau de l’Université Bretagne Loire Thèse en vue du DIPLÔME DÉTAT DE DOCTEUR EN PHARMACIE présentée par Lola TALBOT-COLLIN Normes ISO 9001 & ISO 13485. The certificates issued to you by AJA EUROPE will support your recognition in any country and by any partner or client Normes ISO 9001 & 13485: évolution, comparaison et mise en place au sein d’une startup. We conduct an assessment according to ISO 13485 with the recognized and respected international accreditation UKAS (the UK), IAF member. The ISO 13485 certificate with UKAS accreditation is recognized worldwide.