QM

The introduction and maintenance of a quality management system (QMS) in accordance with the EN ISO 13485 standard is a legal requirement for manufacturers of medical devices. For manufacturers of Class I medical devices, this quality management system must be certified by a notified body.

We can guide and support the development and certification of your QMS by providing bespoke solutions for your company that take your specific needs into account and help to strengthen your business.

Topics

Quality Assurance Manual & SOP (Standard Operating Procedures)

Under the EU Medical Devices Regulation (MDR), medical device manufacturers of all risk classes are required by law to set up quality management systems (QMS) within their companies. Are you at the beginning of this process, or maintaining an existing system? Do you need some general advice, or tailored support on specific issues?

You can rely on the experience of our QM experts and auditors. Feel free to ask them anything you need to know, and let us help you find your way to a QMS that works for you.

Audits

Under the EU Medical Devices Regulation (MDR), medical device manufacturers of all risk classes are required by law to set up quality management systems (QMS) within their companies. Are you at the beginning of this process, or maintaining an existing system? Do you need general advice, or tailored support on specific issues?

You can rely on the experience of our QM experts and auditors. Feel free to ask them anything you need to know, and let us help you find your way to a QMS that works for you.

EN ISO 13485

A quality management system (QMS) is designed to ensure that the quality of systems, processes and products is regularly inspected and improved within your company. The EN ISO 13485 standard describes the requirements for quality management systems for medical device manufacturers. Do you need  general advice, or tailored support to help you develop your system?

Our experienced QM experts and auditors are at your service.

MDR

Medical Devices Regulation (EU) 2017/745, commonly known as MDR, has replaced the European Medical Devices Directive (MDD). Aside from achieving its aim of standardising requirements within EU Member States, the new regulation brings a raft of changes for established manufacturers.

Our experts can provide you with an overview of the new Regulation as well as specific recommendations for your company and your device, so you know exactly where you stand.

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