ISO 13485: 2016 is the central standard for defining the organization of a company operating in the medical device industry
ISO 13485: 2016 is applied primarily by manufacturers and subcontractors but it is also applied by other economic operators, such as importers, distributors, agents and also consulting firms.
MD101 can assist you in setting up a quality management system (QMS) from scratch or in transition from ISO 9001.
Our experts, who have made their careers with manufacturers of non-active or implantable DM as well as electromedical DM or software DM, will define a tailor-made SQM for your company.. MD101 will never impose ready-made templates, made for everyone and useful for no one. The MD101 method is to define the QMS best suited to your needs.
MD101 can also help you choosing your certification body: notified body if you are a manufacturer or other certification bodies if you are another economic operator. MD101 can then accompany you during the certification audits. Our experts can be present on site or remotely to provide you with support in developing the best answers to auditors’ questions
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