To meet the requirements and regulations of medical devices, the implementation of a quality management system (QMS) according to ISO 13485 is mandatory in Europe and strongly recommended in Canada and other countries. When it is not mandatory, it still remains a highly sought-after reference for investors and other partners.
The requirements of this quality management system apply to all organizations, regardless of their size and nature. With the ISO 13485 QMS , you demonstrate your company's ability and commitment to ensuring the safety and quality of your products.
A guarantee of competence and an essential step in obtaining CE marking and placing your medical and health products on the market.
Cisteo CONSULTING assists you in the creation and deployment of your ISO 13485 quality management system for all medical devices up to class III . Our comprehensive support covers the entire spectrum of your regulatory, normative and technical needs:
Often the first question that arises is “Is it mandatory to obtain ISO 13485 certification?” We took advantage of our first webinar “Do you need to be ISO 13485 certified to progress in the world of medical devices?” to answer this question.
The steps leading to ISO 13485 certification are as follows:
Cisteo can assist you in the upstream stages, to define with you the scope of your certification and answer questions concerning the various normative and regulatory obligations. We can also carry out your internal audit , by an ICA auditor , before the certification body passes. In the case of maintaining certification or following an internal audit, we can assist you in upgrading your QMS.
We are here to support you. Let’s discuss your quality project!
