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In fact, this is what many of the organizations in this business do. This means that an organization can uphold the set ISO 13485 regulations but still fail to go for the certification of this standard. It must be noted that ISO 13485 certification is not mandatory for organizations involved in the manufacture of medical devices. Organizations involved in the production of medical devices have a management system that is compliant with the set ISO 13485. To this ISO 13485 was born whose role has been to make sure the production of the medical devices is produced in an environment that guarantees safety. This then resulted in the increased need to make sure that all the medical devices involved in any medical process meet certain compliant regulations. You might want to know why this is so essential but you need to take note of the fact that there have been so many cases in the past where people in medical settings got hurt from the medical devices they were using.Įven though some of these cases could not be avoided, many of them pointed to faulty medical equipment. The aim of doing this is and remains the issue of safety. Our network is able to support you on the 5 continents, we can take care of the quality advice as well for your seats based in France but also in Europe and in the rest of the world.One of the latest attempts to make the medical industry even much safer has been the formation of the ISO 13485 standards which seek to enhance safety in medical settings by offering strict regulations to the companies involved in the manufacture of medical devices. Our French Qualities consultants can intervene in many countries to bring their know-how and their experience. INTERNATIONAL MOBILITY COUNTRY OF INTERVENTION
#FORMATION ISO 13485 MANUAL#
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Environmental management systems – ISO 14001.
#FORMATION ISO 13485 SERIES#
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Guidance on social responsibility – ISO 26000.food safety management system – ISO 22000.Medical devices Quality management systems – ISO 13485.Medical laboratories Quality management systems – ISO 15189.General requirements for the competence of testing and calibration laboratories – ISO 17025,.Design / development, production and, when relevant, installation and servicing of automotive- ISO TS 16949 / IATF 16949 : 2016.Quality Management Systems for Aviation, Space and Defense Organizations – AS 9100.Standards Quality management system – ISO 9001 v2015.STANDARDS AND REFERENCES INTERNATIONAL QUALITY CONSULTANTS With experience in French companies both in advanced industrial fields, digital, FrenchTech, health or aeronautics, we work with our international customers to bring our expertise. International quality consultants work on the following areas : He is able to approach a change management in complex or changing companies.ĪREAS OF EXPERTISE OF FRENCH Quality CONSULTANTS The French International Quality Consultant is an expert in simplicity to aim for sustainable performance. The French Quality Consultant will develop the performance and efficiency of your processes and act on the organization.įinally, it develops performance and efficiency by simple and innovative solutions. It will bring a diversity and a new approach of the Quality approach. In addition, the French Quality Consultant is a real catalyst for your business and your business. Accustomed to work in an environment constrained as well at the regulatory level as human or even technological. He is able to adapt and deploy a set of skills based on French know-how :įrench Tech has significant resources and the French Quality consultant leads your Quality transformation in the best conditions with the minimum of resources. The French Quality Consultant is a real asset for your company. Our consultant know-how is working on the Quality Safety and Environment domains with French companies throughout the year. Certification HAS – Établissement de santéĮxperts in Quality Safety and Environment (QSE), the French Quality consultant work in France but also internationally.ISO 15189 – Laboratoire de biologie médicale.Formation professionnelle Permutateur de Menu.Certification ISO 9001 Permutateur de Menu.