Impact of the MDR on Quality Management Systems (QMS)

All medical devices, whether currently certified to a European Medical Directive or yet to be certified, will need to comply with the requirements of the MDR to be certified under the MDR. The MDR requires manufacturers to demonstrate an effective QMS. Therefore, to receive certification to the MDR, you must have a compliant QMS. […]

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GDPR: What Do I Need to Do Next?

If GDPR applies to your business, it’s worth working to make your systems GDPR compliant. You should consult with your business’s legal team on what exactly compliance means to them, but here are some key considerations: Establish the legal basis for collecting personal data. In most cases, it will be that you have obtained that […]

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What Does GDPR Compliance Mean?

If GDPR applies to your business, it’s worthwhile to know a few of the key objectives of the regulation. First, providing individuals with greater control over how their personal data is used is the heart of the GDPR. A major part of compliance is shifting from operating on the assumption that you can use customers’ […]

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Does GDPR Even Apply to Me?

GDPR is fairly broad in terms of the businesses that it regulates. It applies to two broad strata of companies: (a) those that are “established” in the European Union and (b) those that process data of European Union residents. If your business has a branch in the European Union, seeks to do business with any […]

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European Union’s GDPR

European Union’s General Data Protection Regulation (GDPR) In the 18 months since the European Union’s General Data Protection Regulation (GDPR) has gone into effect, more than $126M in fines have been levied against companies who haven’t complied with the law, including significant fines for Google, British Airways, and Marriott, and all signs point to continued, and possibly even […]

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