Regulatory Affairs

Regulatory Updates

Constantly staying up to date in all areas is hardly possible. Especially when dozens of updated standards and norms are published every month. Dozens of updated standards and norms are published every month. There are countless sources you can tap into, to then spend time and effort filtering which of the changes are relevant to you and your business.

Regulations, standards and updates for MDR / IVDR

Various regulatory authorities, such as the TGA in Australia, even offer consultation procedures in which stakeholders' opinions are solicited. Here, they can comment on planned regulations and thus perhaps even help shape them.

For Medical Devices and IVDs in Europe, there are currently around 300 harmonized standards. And roughly the same amount of applicable standards that are not harmonized. There are already over 80 guidance documents for the MDR / IVDR on the EU website. Not to mention the countless FDA Guidances.

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Use your time wisely and don't waste your valuable resources on the tedious search for the latest Regulatory Updates. Let us be your resource!

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The qtec news: Important updates at a glance

Naturally, there is the option to subscribe to the standard updates and newsletters; but who is expected to read and evaluate them? There is a better way - a way to receive updates that are applicable to you and your company, and arrive regularly and easily.

Take a look at our page in the news section. There you will find some examples of our free Regulatory Affairs Updates. We'll be happy to tailor them to you and your needs.


Use our update service

Our experts are always "up to date". No matter in which market, regardless of the issue: We will ensure that you are regularly informed about all important updates - whilst making sure that they are relevant for you and your company.

Our forms of contract Contact +49 451 808 503 60

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