EN ISO 13485 Quality Management System

QME can assist you, as a subcontractor or manufacturer of (IVD) Medical Devices, with the planning, implementation and maintenance of your EN ISO 13485 Quality Management System.

Assistance during the certification process:

We will guide and support you throughout the entire implementation process of the EN ISO 13485 Quality Management System. Taking the high costs of a certification into consideration, it would be essential that your company obtains its ISO certificate after only one certification audit. QME strives to accomplish this for all customers.

GAP analyses:

Prior to an audit QME can carry out a GAP analysis for your company’s Quality Management System in order to determine potential gaps that can lead to deviations or even blockades during an audit. With this GAP analysis, an action plan can be established.

Temporary quality management:

QME can ensure temporary fulfillment of your QA management, for example for a special project. Temporary support for your own QA manager is also possible.