News

anteris medical will be releasing a number of white papers and useful templates over the next days focussing on medical devices and combination…

The past few years have seen a tremendous development of injectable drugs with devices that allow patients to self-administer their therapy in an…

On 2020, April 1st , TEAM-NB, the European Association for Medical Devices of Notified Bodies, has released a new position paper covering…

In 2017 the Medical Device Regulation (regulation (EU) 2017/745) was released and supposed to replace the Medical Device Directive (directive…

With the revision of the regulatory framework for medical devices in Europe, the Medical Device Regulation (MDR) is also introducing new requirements …

The injection device market is moving quickly, and operating in this market is exciting. All the challenges of device and combination product…

An essential part of quality management according to the General Medicine Act (MPG) and the US FDA's Code of Federal Regulations (CFR), is the…

We had many things to publish and spread over the world last year. At least an interesting White Paper series with different exciting topics.

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The new IVD regulation (IVDR) entered into force almost one and a half years ago. As the date of application for the IVDR is May 26th 2022, this means…