EMA position on new regulatory requirements for Medicinal Products with device constituent part

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

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

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The anteris family of companies has grown!

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Qualification of Equipment as Part of Process Validation for Medical Devices

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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…

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Anteris associates are going to visit the MedTech Summit in Brussels!

Over 550 attendees from the medical device, diagnostics and combination product…

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After the successful kick-off event two years ago, FORUM Science & Health 2019 will focus on the change in medicine: In interactive formats you will…

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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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