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MEDICA
November 18-21, 2019
Dusseldorf, Germany
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30175 Hannover
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Harmonized Standard for Quality Management Systems in the area of Medical Devices updated in 2016


The well-known and proven standard EN ISO 13485 "medical devices – quality management systems – requirements for regulatory purposes" was published in August 2016. It is the task of the top management to raise and maintain quality awareness.

The organizations must establish and organize all necessary processes for the whole life cycle of a medical device, from the development, production, storage and distribution, maintenance and processing, up to the disposal. In addition, there are follow-up processes (Post Market Surveillance) of medical devices and, if applicable, necessary corrective measures.

Also as a supplier of components and modules, you are part of a supply chain within the medical technology industry and are, therefore, obliged to allow unannounced audits by your client or his Notified Body. An up-to-date quality management system allows you to face these inspections with confidence and document compliance with the respective requirements.

The standard supports you with the conformity assessment procedure regarding the fulfilment of the EU directives 90/385/EEC (active implantable devices), 93/42/EEC (medical devices) and 98/79/EC (In-Vitro-Diagnostic) – and also the new Medical Device Regulation and the future In-Vitro-Diagnostic Regulation.

You already have an established quality management system? MDSS Consulting GmbH supports the update of your processes, documents and records in order to successfully pass the audits by your Notified Body.

You are considering documenting and implementing a quality management system pursuant to EN ISO 13485:2016 within your organization? MDSS Consulting GmbH is there for you. Together we substantiate your quality policy, define the accompanying processes, document suitable procedures and work instructions, train your employees and support you to forward the quality concept to every department of your company.

For further information, and to arrange a personal initial conversation, you can reach us through our contact form.